JDIFDA Class 2 · 21 CFR 888.3350 · implantable
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
562
Manufacturers
51
Flagged signals
12
Adverse-event reports
64,376
Code matrix
| FDA product code | JDI |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 48 | 95.7 | 4,404 |
| Other | 2011 | 3 | 53.9 | 108 |
| Other | 2011 | 25 | 49.8 | 1,148 |
| Other | 2013 | 19 | 37.8 | 646 |
| Other | 2012 | 15 | 29.9 | 391 |
| Other | 2010 | 3 | 6.0 | 8 |
| Other | 2014 | 12 | 3.1 | 15 |
| Other | 2010 | 9 | 2.7 | 8 |
| Other | 2012 | 10 | 2.6 | 8 |
| Other | 2015 | 10 | 2.6 | 8 |
| Injury | 2023 | 7 | 2.0 | 4 |
| Injury | 2013 | 7 | 2.0 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 64,376 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Biomet, Inc. | 50 | 2015 | — |
| Depuy, Inc. | 45 | 1998 | — |
| Howmedica Corp. | 35 | 1998 | — |
| Osteonics Corp. | 29 | 1998 | — |
| Zimmer, Inc. | 27 | 2021 | — |
| Intermedics Orthopedics | 21 | 1997 | — |
| Kirschner Medical Corp. | 17 | 1994 | — |
| Howmedica Osteonics Corp. | 16 | 2020 | — |
| Orthomet, Inc. | 16 | 1994 | — |
| Encore Orthopedics, Inc. | 13 | 1999 | — |
| Exactech, Inc. | 12 | 2005 | — |
| DEPUY ORTHOPAEDICS, INC. | 12 | 2009 | — |
| Wrightmedicaltechnologyinc | 11 | 2004 | — |
| Implex Corp. | 10 | 2000 | — |
| Johnson & Johnson Professionals, Inc. | 9 | 1998 | — |
| Smith & Nephew, Inc. | 8 | 2024 | — |
| Richards Medical Co., Inc. | 7 | 1988 | — |
| Orthopedic Systems, Inc. | 7 | 1991 | — |
| BIOPRO, INC. | 7 | 2009 | — |
| Richard'S Medical Equip., Inc. | 7 | 1983 | — |
| Smith & Nephew Richards, Inc. | 7 | 1996 | — |
| Dow Corning Wright | 5 | 1991 | — |
| Stelkast Company | 5 | 1999 | — |
| Corin USA | 4 | 2015 | — |
| Kinamed, Inc. | 3 | 1995 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners · Zimmer Biomet510(k) · 2025-07-31
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems · Smith & Nephew, Inc.510(k) · 2024-10-21
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2024-08-02
Stryker Orthopaedics Hip Systems Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2024-04-12
Global Modular Replacement System · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics510(k) · 2023-12-08
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2023-01-26
C-Stem AMT LE Prosthesis · Depuy Ireland UC510(k) · 2022-07-22
Exeter® X3® RimFit® Cup · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2022-02-01
MPO Hip Instruments · Microport Orthopedics, Inc.510(k) · 2022-01-05
VerSys Cemented Revision/Calcar · Zimmer, Inc.510(k) · 2021-12-10
ELEOS Limb Salvage System with BioGrip · Onkos Surgical510(k) · 2021-06-09
ELEOS Limb Salvage System · Onkos Surgical510(k) · 2021-02-05
ELEOS Limb Salvage System featuring BIOGRIP · Onkos Surgical510(k) · 2020-12-11
PROFEMUR® GLADIATOR® Cemented Classic Stem · Microport Orthopedics, Inc.510(k) · 2020-12-10
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup · Howmedica Osteonics Corp.510(k) · 2020-08-13
ZCA All-Poly Acetabular Cups · Zimmer, Inc.510(k) · 2020-07-16
Zimmer, Inc. Hip Joint Prostheses MR Labeling I · Zimmer, Inc.510(k) · 2020-07-09
CPT Hip System · Zimmer, Inc.510(k) · 2020-03-20
Conformity stem, cemented · United Orthopedic Corporation510(k) · 2020-01-03
EXETER Centralizer, EXETER 2.5mm Plug · Stryker Orthopaedics510(k) · 2019-08-28
Cemented TSI Hip Stem · Signature Orthopaedics Pty, Ltd.510(k) · 2019-02-11
Libertas Hip Replacement System · Maxx Orthopedics, Inc.510(k) · 2018-09-28
MALUC Total Hip Arthroplasty System · Surgtech, Inc.510(k) · 2017-05-10
REDAPT Anteverted Cemented Liner · Smith & Nephew, Inc.510(k) · 2016-11-17
FitRite Total Hip Arthroplasty System · Excera Orthopedics, Inc.510(k) · 2016-06-23
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.