510(k) · Cleared
ClearedMicroPort Orthopedics Total Hip Systems MR Labeling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics Inc. (Mpo) · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 20, 2018 as substantially equivalent to K864626 (Dow Corning Wright, 1986) and 44 other predicates after a 272-day review. Its family tree reaches back 8 generations to 1993. 3 of the 83 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 20, 2018
- Review
- 272 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 45
Its longest line of descent runs back 8 generations to K930712 (1993). 81 ancestors in all, the oldest K811718 (1981). 1 later device descends from it, 1 citing it directly. 3 of the 83 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 7 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 6 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 5 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 3 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 2 generations backK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- 1 generation backK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- This deviceK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
- Descendant · cites it directly · 0 of its ownK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K240452Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −7 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −6 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −5 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −3 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −2 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| −1 | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | 2018 | — |
| +1 | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 1 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 1 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (45)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K864626 | Cancellous Bone ScrewSummary page 14…510(k) Summary Predicate Devices: Table 1: Predicate Table with Submission Numbers and Descriptions Submission Description Number K864626 CANCELLOUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET A… | 1986 |
| * | K883618 | Perfecta II Total Hip SystemSummary page 14…Predicate Devices: Table 1: Predicate Table with Submission Numbers and Descriptions Submission Description Number K864626 CANCELLOUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 S… | 1988 |
| * | K893685 | Ceramic Femoral HeadSummary page 14…e with Submission Numbers and Descriptions Submission Description Number K864626 CANCELLOUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESU… | 1989 |
| * | K931333 | Orthomet Acetabular Cup SystemSummary page 14…iptions Submission Description Number K864626 CANCELLOUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025… | 1994 |
| * | K932222 | SLT Femoral HeadSummary page 14…n Number K864626 CANCELLOUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149… | 1994 |
| * | K944752 | Orthomet Resurfacing Femoral ComponentSummary page 14…OUS BONE SCREW K883618 PERFECTA II TOTAL HIP SYSTEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003… | 1994 |
| * | K953025 | SLT 28MM XXL Femoral HeadSummary page 14…STEM K893685 CERAMIC FEMORAL HEAD K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEN… | 1995 |
| * | K002149 | Lineage Acetabular SystemSummary page 14…K931333 ORTHOMET ACETABULAR CUP SYSTEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346… | 2000 |
| * | K003016 | Pro-Femur RSummary page 14…STEM K932222 SLT FEMORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA00… | 2000 |
| * | K004032 | Perfecta and ExtendSummary page 14…ORAL HEAD K944752 ORTHOMET RESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL… | 2001 |
| * | K012091 | Pro-FemurSummary page 14…ESURFACING FEMORAL COMPONENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995… | 2001 |
| * | K021346 | Stem Hip Replacement System, Model PHA002XXSummary page 14…NENT K953025 SLT 28MM XXL FEMORAL HEAD K002149 LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HI… | 2002 |
| * | K043073 | Procotyl-E Acetabular SystemSummary page 14…LINEAGE ACETABULAR SYSTEM K003016 PRO-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915… | 2005 |
| * | K051995 | Profemur Renaissance Hip StemSummary page 14…O-FEMUR R K004032 PERFECTA AND EXTEND K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PRO… | 2005 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 14…K012091 PRO-FEMUR K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACET… | 2005 |
| * | K052915 | Profemur XTR Hip StemSummary page 14…M HIP REPLACEMENT SYSTEM, MODEL PHA002XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETAB… | 2006 |
| * | K060358 | Profemur TL Hip StemSummary page 14…02XX K043073 PROCOTYL-E ACETABULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR B… | 2006 |
| * | K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerSummary page 14…BULAR SYSTEM K051995 PROFEMUR RENAISSANCE HIP STEM K052026 LINEAGE A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR BIPOLAR SYSTEM K062960 CONSERV… | 2006 |
| * | K062693 | Gladiator Bipolar SystemSummary page 14…A-CLASS POLY LINER K052915 PROFEMUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR BIPOLAR SYSTEM K062960 CONSERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K0726… | 2006 |
| * | K062960 | Conserve Femoral Resurfacing ComponentSummary page 14…MUR XTR HIP STEM K060358 PROFEMUR TL HIP STEM K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR BIPOLAR SYSTEM K062960 CONSERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K072656 DYNASTY CERAMIC FEMORAL HEAD K… | 2006 |
| * | K070785 | Dynasty Acetabular SystemSummary page 14…K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR BIPOLAR SYSTEM K062960 CONSERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K072656 DYNASTY CERAMIC FEMORAL HEAD K082673 CONSERVE PRESSFIT FEMORAL COMPONENT K082… | 2007 |
| * | K072656 | Dynasty Ceramic Femoral HeadSummary page 14…YNASTY A-CLASS POLY ACETABULAR LINER K062693 GLADIATOR BIPOLAR SYSTEM K062960 CONSERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K072656 DYNASTY CERAMIC FEMORAL HEAD K082673 CONSERVE PRESSFIT FEMORAL COMPONENT K082924 DYNASTY POROUS ACETABULAR SHELL… | 2008 |
| * | K082673 | Conserve Pressfit Femoral ComponentSummary page 14…93 GLADIATOR BIPOLAR SYSTEM K062960 CONSERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K072656 DYNASTY CERAMIC FEMORAL HEAD K082673 CONSERVE PRESSFIT FEMORAL COMPONENT K082924 DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACET… | 2008 |
| * | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…Summary page 14…SERVE FEMORAL RESURFACING COMPONENT K070785 DYNASTY ACETABULAR SYSTEM K072656 DYNASTY CERAMIC FEMORAL HEAD K082673 CONSERVE PRESSFIT FEMORAL COMPONENT K082924 DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER K091423 PROFEMUR HIP SYSTEM MOD… | 2009 |
| * | K091423 | Profemur Hip System Modular NecksSummary page 14…AMIC FEMORAL HEAD K082673 CONSERVE PRESSFIT FEMORAL COMPONENT K082924 DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER K091423 PROFEMUR HIP SYSTEM MODULAR NECKS K110399 GLADIATOR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP… | 2009 |
| * | K110399 | Gladiator Plasma Classic Hip StemSummary page 14…T FEMORAL COMPONENT K082924 DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER K091423 PROFEMUR HIP SYSTEM MODULAR NECKS K110399 GLADIATOR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASM… | 2011 |
| * | K111698 | Profemur (R) E Cementless Hip StemSummary page 14…ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER K091423 PROFEMUR HIP SYSTEM MODULAR NECKS K110399 GLADIATOR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP S… | 2011 |
| * | K111699 | Profemur (R) Z Titanium Plasma Sprayed Hip StemSummary page 14…, METAL ACETABULAR LINER K091423 PROFEMUR HIP SYSTEM MODULAR NECKS K110399 GLADIATOR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150… | 2011 |
| * | K111910 | Gladiator Hip StemSummary page 14…DULAR NECKS K110399 GLADIATOR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150 PROFEMUR GLADIATOR HA HIP STEM K121221 PROFEMUR Z REV… | 2011 |
| * | K112080 | Preserve Hip StemSummary page 14…OR PLASMA CLASSIC HIP STEM K111698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150 PROFEMUR GLADIATOR HA HIP STEM K121221 PROFEMUR Z REVISION HIP STEM K123434 PROF… | 2011 |
| * | K112150 | Profemur Gladiator HA Hip StemSummary page 14…698 PROFEMUR(R) E CEMENTLESS HIP STEM K111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150 PROFEMUR GLADIATOR HA HIP STEM K121221 PROFEMUR Z REVISION HIP STEM K123434 PROFEMUR Z CLASSIC STEMS… | 2011 |
| * | K121221 | Profemur Z Revision Hip StemSummary page 14…111699 PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150 PROFEMUR GLADIATOR HA HIP STEM K121221 PROFEMUR Z REVISION HIP STEM K123434 PROFEMUR Z CLASSIC STEMS… | 2012 |
| * | K123434 | Profemur Z Classic StemsSummary page 14…PRAYED HIP STEM K111910 GLADIATOR HIP STEM K112080 PRESERVE HIP STEM K112150 PROFEMUR GLADIATOR HA HIP STEM K121221 PROFEMUR Z REVISION HIP STEM K123434 PROFEMUR Z CLASSIC STEMS… | 2013 |
| * | K123688 | Profemur TL Classic Hip StemSummary page 15…510(k) Summary Table 1: Predicate Table with Submission Numbers and Descriptions (cont.) Submission Description Number K123688 PROFEMUR TL CLASSIC HIP STEM K130167 PROFEMUR XM DISTAL CENTRALIZER K130376 DYNASTY ACETABULAR SYSTEM WITH CERAM… | 2013 |
| * | K130167 | Profemur XM Distal CentralizerSummary page 15…ary Table 1: Predicate Table with Submission Numbers and Descriptions (cont.) Submission Description Number K123688 PROFEMUR TL CLASSIC HIP STEM K130167 PROFEMUR XM DISTAL CENTRALIZER K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC K130984 PROFEMUR RENAISSANCE CLASS… | 2013 |
| * | K130376 | Dynasty Acetabular System with CeramicSummary page 15…Numbers and Descriptions (cont.) Submission Description Number K123688 PROFEMUR TL CLASSIC HIP STEM K130167 PROFEMUR XM DISTAL CENTRALIZER K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM K140043 DYNASTY SHELL, DYNA… | 2013 |
| * | K130984 | Profemur Renaissance Classic Hip StemSummary page 15…Description Number K123688 PROFEMUR TL CLASSIC HIP STEM K130167 PROFEMUR XM DISTAL CENTRALIZER K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMO… | 2013 |
| * | K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadSummary page 15…L CLASSIC HIP STEM K130167 PROFEMUR XM DISTAL CENTRALIZER K130376 DYNASTY ACETABULAR SYSTEM WITH CERAMIC K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD K140676 PROFEMUR TL CLASSIC LONG NECK… | 2014 |
| * | K140676 | Profemur TL Classic Long Neck Hip StemsSummary page 15…R SYSTEM WITH CERAMIC K130984 PROFEMUR RENAISSANCE CLASSIC HIP STEM K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS K142119 PROCOTY… | 2014 |
| * | K141235 | Profemur Renaissance Classic Long Neck Hip StemsSummary page 15…CE CLASSIC HIP STEM K140043 DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS K142119 PROCOTYL L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserv… | 2014 |
| * | K142119 | Procotyl L-O Acetabular SystemSummary page 15…S CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS K142119 PROCOTYL L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserve Size 1-3 Hip Stems K150302 PROFEMUR Preserve Classic St… | 2015 |
| * | K150133 | PROFEMUR Preserve Size 1-3 Hip StemsSummary page 15…L HEAD K140676 PROFEMUR TL CLASSIC LONG NECK HIP STEMS K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS K142119 PROCOTYL L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserve Size 1-3 Hip Stems K150302 PROFEMUR Preserve Classic Stem K170444 PROCOTYL PRIME ACETABULAR CU… | 2015 |
| * | K150302 | PROFEMUR Preserve Classic StemSummary page 15…HIP STEMS K141235 PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS K142119 PROCOTYL L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserve Size 1-3 Hip Stems K150302 PROFEMUR Preserve Classic Stem K170444 PROCOTYL PRIME ACETABULAR CUP SYSTEM K171181 PROCOTYL® PRIME E-CLASS™ XLP… | 2015 |
| * | K170444 | PROCOTYL® PRIME Acetabular Cup SystemSummary page 15…CLASSIC LONG NECK HIP STEMS K142119 PROCOTYL L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserve Size 1-3 Hip Stems K150302 PROFEMUR Preserve Classic Stem K170444 PROCOTYL PRIME ACETABULAR CUP SYSTEM K171181 PROCOTYL® PRIME E-CLASS™ XLPE Liner Device Description The only changes… | 2017 |
| * | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE LinerSummary page 15…L-O ACETABULAR SYSTEM K150133 PROFEMUR Preserve Size 1-3 Hip Stems K150302 PROFEMUR Preserve Classic Stem K170444 PROCOTYL PRIME ACETABULAR CUP SYSTEM K171181 PROCOTYL® PRIME E-CLASS™ XLPE Liner Device Description The only changes to the subject hip systems are updates to the labe… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240452 | Ceramic Femoral Head | 2024 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
- K003016Pro-Femur RWrightmedicaltechnologyinc · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 15 of the 81 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K240452 (Microport Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K864626.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
CANCELLOUS BONE SCREW This cancellous bone screw is indicated for use where screw purchase with cancellous bone is required. PERFECTA II TOTAL HIP SYSTEM The Perfecta II Hip System is intended for cemented application only. The prosthesis system will be used in indications which are the same as indications for other cemented total hip designs such as the Zimmer Harris/Galante, the Biomet Bimetric, the Harris Precoat and the Howmedica Precision Hip…
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CANCELLOUS BONE SCREW
This cancellous bone screw is indicated for use where screw purchase with cancellous bone is required.
PERFECTA II TOTAL HIP SYSTEM
The Perfecta II Hip System is intended for cemented application only. The prosthesis system will be used in indications which are the same as indications for other cemented total hip designs such as the Zimmer Harris/Galante, the Biomet Bimetric, the Harris Precoat and the Howmedica Precision Hip System. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma or complications from failed prostheses.
CERAMIC FEMORAL HEAD
The McCutchen Femoral Hip Prothesis is indicated for relief of pain and restoration of hip function in skeletally mature patients with: bicompartmental joint disease secondary to osteoarthritis, rheumatoid arthritis or traumatic arthritis, avascular necrosis of the femoral head, painful hip dyplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, revision procedures for which an adequate fit may be achieved by the operating surgeon at the time of surgery. This hip stem prosthesis can be used with all short, medium, and long 28 and 32mm Ceramic Femoral Heads.
ORTHOMET ACETABULAR CUP SYSTEM
The intended use for the Orthomet Acetabular Cup System is identical to that of the acetabular cups of the Orthomet PERFECTA Total Hip System. The Orthomet Acetabular Cup is intended for cemented application only. Indications for the Orthomet Acetabular Cup will remain the same as indications for the original acetabular components of the PERFECTA Total Hip system and other acetabular cup systems currently available in commercial distribution, such as the Depuy Solution Acetabular Cup, Intermedics APR Acetabular Cup, Joint Medical Products S-ROM Acetabular Cup, Smith & Nephew Richards opti-Fix Acetabular Cup, and smith & Nephew Richards Reflection Acetabular Cup. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma, or complications from failed prostheses.
SLT FEMORAL HEAD
This femoral head can only be used with stems labeled for use with this product, and the stem labeling should be consulted to determine its compatibility with this product. The SLT Femoral Head may be used with appropriately sized polyethylene-lined acetabular cups or bipolar endoprostheses.
ORTHOMET RESURFACING FEMORAL COMPONENT
The Orthomet Resurfacing Femoral Component (from this point forward referred to as the Resurfacing Femoral Component) is intended for single use in a cemented application only. The Resurfacing Femoral Component will be used in indications which are the same as indications for other commercially available femoral resurfacing components such as the Endotec Integrated Resurfacing Hip, DePuy Indiana Conservative Hip, DePuy T.A.R.A. Hemi Articular Hip Replacement, and Zimmer THARIES Surface Replacement System. Some indications include resurfacing of the femoral head portion of the hip joint due to avascular necrosis, degenerative bone disease, trauma, or complications from failed prostheses.
SLT 28MM XXL FEMORAL HEAD
The SLT 28mm XXL Femoral Head is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
LINEAGE ACETABULAR SYSTEM
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
PRO-FEMUR R
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
PERFECTA AND EXTEND
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
PRO-FEMUR
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques.
PROCOTYL-E ACETABULAR SYSTEM
The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of fractures that are unmanageable using other techniques. The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.
PROFEMUR RENAISSANCE HIP STEM
The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
LINEAGE A-CLASS POLY LINER
Indications For Use: The LINEAGE® A-CLASS™ Poly Liner is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
PROFEMUR XTR HIP STEM
The PROFEMUR® XTR Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
PROFEMUR TL HIP STEM
The PROFEMUR® TL Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER
The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
GLADIATOR BIPOLAR SYSTEM
The GLADIATOR® Bipolar System is indicated for the following conditions: 1. pathological fractures of the femoral neck. 2. non-union of femoral neck fractures. 3. aseptic necrosis of the femoral head and neck. 4. primary pathology in the young involving the femoral head but with non-deformed acetabulum.
CONSERVE FEMORAL RESURFACING COMPONENT
The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.
DYNASTY ACETABULAR SYSTEM
The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.
DYNASTY CERAMIC FEMORAL HEAD
The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The DYNASTY™ Acetabular Shell is for both cemented and uncemented use.
CONSERVE PRESSFIT FEMORAL COMPONENT
The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use.
DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER
The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision. The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device.
PROFEMUR HIP SYSTEM MODULAR NECKS
The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.
GLADIATOR PLASMA CLASSIC HIP STEM
The GLADIATOR® Plasma Classic Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The GLADIATOR® Plasma Classic Hip Stem are intended for use during uncemented hip arthroplasty.
PROFEMUR(R) E CEMENTLESS HIP STEM
The PROFEMUR® E Cementless Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
GLADIATOR HIP STEM
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Gladiator Cemented hip stem is intended for cemented hip arthroplasty.
PRESERVE HIP STEM
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Preserve hip stem is intended for cementless hip arthroplasty.
PROFEMUR GLADIATOR HA HIP STEM
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.
PROFEMUR Z REVISION HIP STEM
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
PROFEMUR Z CLASSIC STEMS
The PROFEMUR® Z Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
PROFEMUR TL CLASSIC HIP STEM
The PROFEMUR® TL Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® TL Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
PROFEMUR XM DISTAL CENTRALIZER
The PMMA Distal Centralizers are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed.
PROFEMUR RENAISSANCE CLASSIC HIP STEM
The PROFEMUR® RENAISSANCE® Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® RENAISSANCE® Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. Shells with BIOFOAM metal foam coating are intended only for uncemented arthroplasty. Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty.
PROFEMUR TL CLASSIC LONG NECK HIP STEMS
The PROFEMUR® TL Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® TL Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.
PROCOTYL L-O ACETABULAR SYSTEM
The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
PROFEMUR Preserve Size 1-3 Hip Stems
The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
PROFEMUR Preserve Classic Stem
The PROFEMUR® Preserve Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Preserve Classic Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
PROCOTYL PRIME ACETABULAR CUP SYSTEM
The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
PROCOTYL® PRIME E-CLASS™ XLPE Liner
The PROCOTYL® PRIME E-CLASS™ XLPE Liner is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173898: MicroPort Orthopedics Total Hip Systems MR Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173898
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026