HSDFDA Class 2 · 21 CFR 888.3690 · implantable
Prosthesis, Shoulder, Hemi-, Humeral, Metallic 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
71
Manufacturers
26
Flagged signals
15
Adverse-event reports
9,185
Code matrix
| FDA product code | HSD |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3690 |
| 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 | 15 | 87.5 | 1,199 |
| Other | 2010 | 14 | 81.7 | 1,038 |
| Other | 2011 | 7 | 40.8 | 234 |
| Other | 2014 | 16 | 18.7 | 251 |
| Other | 2013 | 3 | 17.5 | 32 |
| Other | 2013 | 10 | 11.7 | 87 |
| Other | 2013 | 9 | 10.5 | 68 |
| Other | 2012 | 9 | 10.5 | 68 |
| Other | 2013 | 7 | 5.7 | 23 |
| Other | 2015 | 6 | 4.9 | 15 |
| Other | 2010 | 4 | 4.7 | 8 |
| Injury | 2016 | 4 | 2.6 | 4 |
| Injury | 2025 | 6 | 2.6 | 7 |
| Injury | 2012 | 5 | 2.6 | 6 |
| Injury | 2017 | 16 | 2.1 | 13 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 9,185 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Howmedica Osteonics Corp. | 6 | 2007 | — |
| ARTHREX, INC. | 5 | 2024 | — |
| DEPUY ORTHOPAEDICS, INC. | 4 | 2008 | — |
| Exactech, Inc. | 4 | 2013 | — |
| Biomet, Inc. | 4 | 2005 | — |
| Tornier | 3 | 2006 | — |
| Intermedics Orthopedics | 3 | 1996 | — |
| Tecres S.p.A. | 2 | 2011 | — |
| Kirschner Medical Corp. | 2 | 1988 | — |
| Arthrosurface, Inc. | 2 | 2018 | — |
| FX SOLUTIONS | 2 | 2013 | — |
| Depuy, Inc. | 2 | 1991 | — |
| Ascension Orthopedics, Inc. | 2 | 2007 | — |
| Howmedica Corp. | 2 | 1996 | — |
| Synthes (Usa) | 1 | 2007 | — |
| Wrightmedicaltechnologyinc | 1 | 1995 | — |
| Zimmer GmbH | 1 | 2016 | — |
| implantcast GmbH | 1 | 2020 | — |
| Stryker Orthopaedics | 1 | 2005 | — |
| Smith & Nephew, Inc. | 1 | 2012 | — |
| Biocore9, LLC | 1 | 2020 | — |
| Corin USA | 1 | 2002 | — |
| ENDOTEC, INC. | 1 | 1999 | — |
| Lima Corporate S.P.A. | 1 | 2012 | — |
| Acu Med, Inc. | 1 | 2000 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Univers Revers CA Head and Adapter · Arthrex, Inc.510(k) · 2024-02-12
Univers Revers Humeral Cup Implant · Arthrex, Inc.510(k) · 2022-05-19
AGILON® XO Shoulder Replacement System · Implantcast GmbH510(k) · 2020-11-12
Biocore9 Humeral Resurfacing System · Biocore9, LLC510(k) · 2020-05-15
OVOMotion Shoulder Arthroplasty System · Arthrosurface, Inc.510(k) · 2018-04-18
Arthrex Univers Revers Shoulder Prosthesis System · Arthrex, Inc.510(k) · 2016-11-21
Anatomical Shoulder Domelock Dome centric · Zimmer GmbH510(k) · 2016-11-01
Arthrex Univers Revers CA Heads and Adapters · Arthrex, Inc.510(k) · 2016-04-19
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System · Arthrosurface, Inc.510(k) · 2014-12-19
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM · Exactech, Inc.510(k) · 2013-11-26
HUMELOCK II CEMENTLESS SHOULDER SYSTEM · Fx Solutions510(k) · 2013-11-09
ARTHREX UNIVERS II CA HEADS · Arthrex, Inc.510(k) · 2013-10-30
SEVIIN SURFACE REPLACEMENT SHOULDER · Ingen Orthopedics, LLC510(k) · 2013-08-26
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS · Smith & Nephew, Inc.510(k) · 2012-09-07
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS · Lima Corporate S.P.A.510(k) · 2012-06-01
SPACER-S · Tecres S.P.A.510(k) · 2011-12-12
HUMELOCK CEMENTED SHOULDER PROSTHESIS · Fx Solutions510(k) · 2011-11-09
DEPUY GLOBAL AP CTA HUMERAL HEAD · DePuy Orthopaedics, Inc.510(k) · 2008-12-18
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER · DePuy Orthopaedics, Inc.510(k) · 2008-08-08
DVO EXTENDED ARTICULATION HUMERAL HEADS · Dvo Extremity Solutions, LLC510(k) · 2008-02-19
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM · Synthes (Usa)510(k) · 2007-11-28
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA · Ascension Orthopedics, Inc.510(k) · 2007-06-22
REUNION HA FRACTURE STEM · Howmedica Osteonics Corp.510(k) · 2007-05-04
PROMOS MODULAR SHOULDER SYSTEM · Plus Orthopedics AG510(k) · 2007-03-02
AEQUALIS RESURFACING HEAD · Tornier510(k) · 2006-12-22
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.