KWYFDA Class 2 · 21 CFR 888.3390 · implantable
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
99
Manufacturers
39
Flagged signals
15
Adverse-event reports
12,807
Code matrix
| FDA product code | KWY |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| 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 | 2012 | 8 | 71.9 | 491 |
| Other | 2012 | 21 | 68.2 | 1,324 |
| Other | 2010 | 7 | 62.9 | 367 |
| Other | 2013 | 13 | 42.2 | 483 |
| Other | 2011 | 12 | 38.9 | 407 |
| Other | 2010 | 11 | 35.7 | 337 |
| Other | 2009 | 3 | 27.0 | 51 |
| Other | 2012 | 20 | 20.8 | 358 |
| Other | 2013 | 12 | 12.5 | 116 |
| Other | 2014 | 3 | 9.7 | 16 |
| Other | 2014 | 4 | 4.2 | 7 |
| Injury | 2011 | 29 | 2.4 | 35 |
| Injury | 2012 | 9 | 2.4 | 9 |
| Injury | 2024 | 22 | 2.2 | 22 |
| Injury | 2011 | 9 | 2.1 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 12,807 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Johnson & Johnson Professionals, Inc. | 9 | 1998 | — |
| Biomet, Inc. | 5 | 2005 | — |
| Ortho Development Corp. | 5 | 2005 | — |
| 3M COMPANY | 4 | 1990 | — |
| Howmedica Corp. | 4 | 1994 | — |
| Intermedics Orthopedics | 3 | 1994 | — |
| Kirschner Medical Corp. | 3 | 1991 | — |
| Exactech, Inc. | 3 | 2001 | — |
| Zimmer GmbH | 2 | 2019 | — |
| Zimmer, Inc. | 2 | 1988 | — |
| Heraeus Medical GmbH | 2 | 2022 | — |
| Depuy, Inc. | 2 | 1995 | — |
| BIOPRO, INC. | 2 | 2010 | — |
| WALDEMAR LINK GmbH & Co. KG | 2 | 2022 | — |
| UNITED ORTHOPEDIC CORP. | 2 | 2010 | — |
| CORENTEC CO., LTD. | 1 | 2011 | — |
| Orthopedic Systems, Inc. | 1 | 1988 | — |
| Biomet Manufacturing Corp | 1 | 2008 | — |
| ONKOS SURGICAL, INC. | 1 | 2018 | — |
| Acu Med, Inc. | 1 | 1990 | — |
| Carbomedics, Inc. | 1 | 1984 | — |
| Encore Orthopedics, Inc. | 1 | 1995 | — |
| B-ONE ORTHO, CORP. | 1 | 2026 | — |
| United Orthopedic Corporation | 1 | 2016 | — |
| Omni Life Science, Inc. | 1 | 2009 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
b-ONE® Bipolar Head · B-One Ortho, Corp.510(k) · 2026-04-13
Maxx Libertas Bipolar Hip Head (Bipolar Hip) · Maxx Orthopedics, Inc.510(k) · 2025-08-25
CORAIL Cemented Femoral Stem · Depuy Ireland UC510(k) · 2023-12-19
SpaceFlex Acetabular Cup · G21, S.R.L.510(k) · 2023-03-23
Vario-Cup System · Waldemar Link GmbH & Co. KG510(k) · 2022-07-20
COPAL exchange G hip spacer · Heraeus Medical GmbH510(k) · 2022-03-23
Kyocera Bipolar Hip System · Kyocera Medical Technologies, Inc.510(k) · 2020-04-17
Fitmore Hip Stem · Zimmer GmbH510(k) · 2019-11-05
COPAL exchange G Hip and Knee Spacers · Heraeus Medical GmbH510(k) · 2019-11-01
iNSitu Bipolar Hip System · Theken Companies, LLC510(k) · 2019-09-17
Implantcast ic-Bipolar Head System · Implantcast GmbH510(k) · 2019-08-28
Corin BiPolar-i · Corin U.S.A. Limited510(k) · 2019-06-05
SurgTech Bipolar Head System · Surgtech, Inc.510(k) · 2018-06-14
ELEOS Bipolar Acetabular System · Onkos Surgical, Inc.510(k) · 2018-02-23
40-42mm BiPolar Head and 22mm Femoral Head · Signature Orthopaedics Pty, Ltd.510(k) · 2018-01-29
Fitmore® Hip Stem · Zimmer GmbH510(k) · 2017-02-07
U2 Bipolar Implant and 22mm Femoral Head · United Orthopedic Corporation510(k) · 2016-04-07
Klassic BiPolar System · Total Joint Orthopedics510(k) · 2015-01-28
RING-LOK MODULAR BIPOLAR SYSTEM · Implants International, Ltd.510(k) · 2014-02-07
RENOVIS BIPOLAR HIP SYSTEM · Renovis Surgical Technologies, LLC510(k) · 2013-09-19
DEPUY CORAIL AMT HIP PROSTHESIS · Depuy France S.A.S.510(k) · 2013-09-16
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT · Tgm Medical, Inc.510(k) · 2012-11-05
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP · Corentec Co., Ltd.510(k) · 2011-10-12
BIOPRO POLAR HEAD · Biopro, Inc.510(k) · 2010-12-03
UNITED U2 BIPOLAR IMPLANT · United Orthopedic Corp.510(k) · 2010-10-08
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.