510(k) · Cleared
ClearedMPO Hip Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 5, 2022 as substantially equivalent to K140676 (Microport Orthopedics, Inc., 2014) and 7 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1993. 2 of the 57 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 5, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K930712 (1993). 56 ancestors in all, the oldest K851422 (1985). No later device cites it as a predicate yet. 2 of the 57 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 backK190123 MicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc. · 2019
- This deviceK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022
Class I recalls in this family
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 | K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics, Inc. | 2019 | — |
| 0 (this device) | K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 1 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K140676 | Profemur TL Classic Long Neck Hip StemsSummary page 4…I, LPH, MBL, KWL, Panel Code: KWY Primary Predicate Device: PROFEMUR® TL CLASSIC LONG NECK HIP STEMS (K140676) Predicate Devices: PROFEMUR® RENAISSANCE® CLASSIC LONG NECK HIP STEMS (K1412… | 2014 |
| * | K141235 | Profemur Renaissance Classic Long Neck Hip StemsSummary page 4…S (K140676) Predicate Devices: PROFEMUR® RENAISSANCE® CLASSIC LONG NECK HIP STEMS (K141235) PROFEMUR® Preserve Size 1-3 Hip Stems (K150133)… | 2014 |
| * | K150133 | PROFEMUR Preserve Size 1-3 Hip StemsSummary page 4…PROFEMUR® RENAISSANCE® CLASSIC LONG NECK HIP STEMS (K141235) PROFEMUR® Preserve Size 1-3 Hip Stems (K150133) Page 1 of 3… | 2015 |
| * | K150302 | PROFEMUR Preserve Classic StemSummary page 5…K213816: 510(k) Summary PROFEMUR® Preserve Classic Stem (K150302) Prime Acetabular Cup System (K170444) MicroPort CoCr Fem… | 2015 |
| * | K170444 | PROCOTYL® PRIME Acetabular Cup SystemSummary page 5…K213816: 510(k) Summary PROFEMUR® Preserve Classic Stem (K150302) Prime Acetabular Cup System (K170444) MicroPort CoCr Femoral Heads (K190123) PROFEMUR® TL2 Ste… | 2017 |
| * | K190123 | MicroPort CoCr Femoral HeadsSummary page 5…eserve Classic Stem (K150302) Prime Acetabular Cup System (K170444) MicroPort CoCr Femoral Heads (K190123) PROFEMUR® TL2 Stems (K191632) PROFEMUR® GLADIATOR® Cemen… | 2019 |
| * | K191632 | PROFEMUR TL2 StemsSummary page 5…Prime Acetabular Cup System (K170444) MicroPort CoCr Femoral Heads (K190123) PROFEMUR® TL2 Stems (K191632) PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519) DE… | 2019 |
| * | K201519 | PROFEMUR® GLADIATOR® Cemented Classic StemSummary page 5…PROFEMUR® TL2 Stems (K191632) PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519) DEVICE INFORMATION A. Device Description The device modification consists of an alteration to the sterilization instruc… | 2020 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 56 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K140676.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use. 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: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli…
Read the full statement (152 words)
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.
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:
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
Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.
PRIME shells are intended only for uncemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213816: MPO Hip Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213816
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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