510(k) · Cleared
ClearedEthylene Oxide Sterilization Supplier Change for MPO Hips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 18, 2024 as substantially equivalent to K002149 (Wrightmedicaltechnologyinc, 2000) and 18 other predicates after a 101-day review. Its family tree reaches back 13 generations to 1981. 2 of the 121 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 18, 2024
- Review
- 101 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 19
Its longest line of descent runs back 13 generations to K810258 (1981). 120 ancestors in all. No later device cites it as a predicate yet. 2 of the 121 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 2 generations backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- 1 generation backK200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc. · 2021
- This deviceK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 5 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- 4 generations backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- 3 generations backK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- 2 generations backK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
- 1 generation backK200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc. · 2021
- This deviceK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −5 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| −4 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| −3 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| −2 | K161190 | G7 Dual Mobility System, Active Articulation System | Biomet, Inc. | 2016 | — |
| −1 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. | 2021 | — |
| 0 (this device) | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 1 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 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.
2 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (19)
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 |
|---|---|---|---|
| * | K002149 | Lineage Acetabular SystemSummary page 4…known) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) LINEAGE ACETABULAR SYSTEM (indications identical to K002149) Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature… | 2000 |
| * | K052026 | Lineage a-Class Poly LinerSummary page 5…nown) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) LINEAGE A-CLASS POLY LINER (indications identical to K052026) The LINEAGE® A-CLASS Poly Liner is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved… | 2005 |
| * | K061547 | Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular LinerSummary page 6…ide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER (indications identical to K061547) The DYNASTYTM Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved… | 2006 |
| * | K062693 | Gladiator Bipolar SystemSummary page 7…known) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) GLADIATOR BIPOLAR SYSTEM (indications identical to K062693) The GLADIATORTm Bipolar System is indicated for the following conditions: 1) pathological fractures of the femoral neck 2) no… | 2006 |
| * | K070785 | Dynasty Acetabular SystemSummary page 8…known) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) Dynasty Acetabular System (indications identical to K070785) The Dynasty Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hi… | 2007 |
| * | K072656 | Dynasty Ceramic Femoral HeadSummary page 9…wn) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) DYNASTY CERAMIC FEMORAL HEAD (indications identical to K072656) The DYNASTYTM Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved… | 2008 |
| * | K111910 | Gladiator Hip StemSummary page 10…er (if known) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) GLADIATOR HIP STEM (indications identical to K111910) The Gladiator Hip Stems are intended for use in uncemented and cemented total hip arthroplasty for reduction or relief of pain… | 2011 |
| * | K140043 | Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral HeadSummary page 11…Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) DYNASTY® Acetabular System with Ceramic (indications identical to K140043) MicroPort total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip… | 2014 |
| * | K142119 | Procotyl L-O Acetabular SystemSummary page 12…) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) PROCOTYL L-O ACETABULAR SYSTEM (indications identical to K142119) The PROCOTYL L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improve… | 2015 |
| * | K170444 | PROCOTYL® PRIME Acetabular Cup SystemSummary page 13…46 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) PROCOTYL® PRIME Acetabular Cup System (indications identical to K170444) The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or… | 2017 |
| * | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE LinerSummary page 14…0046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) PROCOTYL® PRIME E-CLASS™ XLPE Liner (indications identical to K171181) PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip fu… | 2017 |
| * | K180798 | Prime Acetabular Cup SystemSummary page 16…own) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) Prime Acetabular Cup System (indications identical to K180798) Indications for Use 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, prot… | 2018 |
| * | K181598 | Prime E-CLASS XLPE LinerSummary page 17…nown) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) Prime E-CLASS™ XI PE Liner (indications identical to K181598) Indications for Use 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, prot… | 2018 |
| * | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSSummary page 18…de Sterilization Supplier Change for MPO Hips Indications for Use (Describe) E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (indications identical to K200011) The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for… | 2021 |
| * | K892398 | Bipolar Hip SystemSummary page 19…(if known) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) Bipolar Hip System (indications identical to K892398) The Bipolar Hip System is intended for cemented and cementless applications. Some indications include replacement of the femora… | 1989 |
| * | K911052 | Nexus (TM) Femoral Hip StemSummary page 20…wn) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) NEXUS FEMORAL HIP PROSTHESIS (indications identical to K911052) The NEXUS Femoral Hip Prosthesis is indicated for relief of pain and restoration of hip function in skeletally mature patients… | 1991 |
| * | K923909 | Cement Restrictor for Proforma and Perfecta TotalSummary page 21…ne Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) Cement Restrictor for Proforma & PERFECTA Total Hip Systems (indications identical to K923909) The Orthomet Cement Restrictor is intended to be used with the PROFORMA and PERFECTA Femoral Stems as part of the PROFORMA and… | 1992 |
| * | K931333 | Orthomet Acetabular Cup SystemSummary page 22…) K240046 Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) ORTHOMET ACETABULAR CUP SYSTEM (indications identical to K931333) The intended use for the Orthomet Acetabular Cup System is identical to that of the acetabular cups of the Orthomet PERFECTA To… | 1994 |
| * | K173776 | BIOLOX delta Option and Extra-long HeadsSummary page 15…Device Name Ethylene Oxide Sterilization Supplier Change for MPO Hips Indications for Use (Describe) BIOLOX® Delta Option and Extra-long Heads (indications identical to K173776) MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 43 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 28 of the 120 ancestors have a recall of any class; 2 have a Class I recall.
- 10 other devices also cite its predicate K002149.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
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 osteoarthlitis, 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…
Read the full statement (1,576 words)
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 osteoarthlitis, 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
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
The DYNASTYTM 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 GLADIATORTm 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 a non-deformed acetabulum.
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.
The DYNASTYTM 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 DYNASTYTM Acetabular Shell is for both cemented and uncemented use.
The Gladiator Hip Stems are intended for use in uncemented and cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
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 Cemented hip stem is intended for cemented hip arthroplasty.
MicroPort 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
Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty
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 conjuction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
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 hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
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.
MicroPort total hip systems 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.
Indications for Use
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.
Indications for Use
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.
The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.
Indications for Use:
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;
5) dislocation risks;
6) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement which are unmanageable by other techniques
Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.
The Bipolar Hip System is intended for cemented and cementless applications. Some indications include replacement of the femoral head of the hip joint due to degenerative bone disease, trauma, non-union or avascular necrosis.
The NEXUS Femoral Hip Prosthesis 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 dysplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, and revision procedures for which an adequate fit may be achieved by the operating surgeon at the time of surgery.
The Orthomet Cement Restrictor is intended to be used with the PROFORMA and PERFECTA Femoral Stems as part of the PROFORMA and PERFECTA Total Hip Systems. The intended use of the Orthomet PROFORMA and PERFECTA Femoral Stems implanted with the Cement Restrictor will remain the same as indications for femoral stems implanted without the Cement Restrictor. Some indications include replacement of the femoral head of the hip joint due to degenerative bone disease, trauma, non-union, avascular necrosis, or complications from failed prostheses. The Orthomet Cement Restrictor is designed to prevent the bone cement from extruding down the medullary canal, during cemented application, when the femoral stem is inserted or the cement is pressurized.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240046
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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