KWSFDA Class 2 · 21 CFR 888.3660 · implantable
Prosthesis, Shoulder, 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
190
Manufacturers
38
Flagged signals
17
Adverse-event reports
20,851
Code matrix
| FDA product code | KWS |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3660 |
| 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 | 230 | 33.4 | 7,167 |
| Other | 2013 | 217 | 31.5 | 6,354 |
| Other | 2011 | 190 | 27.6 | 4,823 |
| Other | 2010 | 125 | 18.1 | 2,000 |
| Other | 2014 | 7 | 11.8 | 59 |
| Other | 2014 | 7 | 11.8 | 59 |
| Other | 2014 | 22 | 11.1 | 192 |
| Other | 2015 | 6 | 10.1 | 41 |
| Other | 2013 | 20 | 10.1 | 154 |
| Other | 2014 | 68 | 9.8 | 531 |
| Other | 2013 | 3 | 5.1 | 6 |
| Other | 2013 | 8 | 4.0 | 15 |
| Other | 2015 | 24 | 3.5 | 40 |
| Other | 2011 | 6 | 3.0 | 6 |
| Injury | 2014 | 9 | 2.6 | 12 |
| Injury | 2012 | 8 | 2.6 | 10 |
| Other | 2013 | 18 | 2.6 | 16 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 20,851 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| ARTHREX, INC. | 15 | 2023 | — |
| Tornier | 12 | 2011 | — |
| Smith & Nephew, Inc. | 11 | 2026 | — |
| TORNIER, INC. | 11 | 2019 | — |
| DEPUY ORTHOPAEDICS, INC. | 9 | 2009 | — |
| Encore Medical L.P. | 9 | 2023 | — |
| Exactech, Inc. | 8 | 2022 | — |
| Lima Corporate S.P.A. | 8 | 2019 | — |
| Tornier S.A.S. | 8 | 2021 | — |
| Osteonics Corp. | 7 | 1996 | — |
| Materialise NV | 5 | 2019 | — |
| Sulzer Orthopedics, Inc. | 5 | 2001 | — |
| Stryker GmbH | 5 | 2021 | — |
| Howmedica Osteonics Corp. | 4 | 2011 | — |
| Intermedics Orthopedics | 4 | 1996 | — |
| Biomet, Inc. | 4 | 2021 | — |
| Zimmer GmbH | 4 | 2016 | — |
| Zimmer, Inc. | 3 | 2020 | — |
| CUSTOM ORTHOPAEDIC SOLUTIONS, INC. | 3 | 2017 | — |
| Encore Orthopedics, Inc. | 3 | 2001 | — |
| Richards Medical Co., Inc. | 2 | 1986 | — |
| Howmedica Corp. | 2 | 1983 | — |
| ENDOTEC, INC. | 2 | 1991 | — |
| Medacta International S.A. | 2 | 2025 | — |
| Wrightmedicaltechnologyinc | 2 | 2000 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
AETOS Shoulder System - CONCELOC Glenoids · Smith & Nephew, Inc.510(k) · 2026-04-06
Catalyst F1x Shoulder System · Catalyst Orthoscience, Inc.510(k) · 2025-11-06
AETOS Shoulder System Meta Humeral Prosthesis Size 0 · Smith & Nephew, Inc.510(k) · 2025-10-29
MyShoulder Planner (5.3SSWPL) · Medacta International S.A.510(k) · 2025-01-30
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) · Stryker Corporation (Tornier, Inc.)510(k) · 2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS) · Stryker Corporation (Tornier, Inc.)510(k) · 2024-09-10
Arthrex Univers Apex OptiFit Humeral Stem · Arthrex, Inc.510(k) · 2023-09-26
AltiVate® Anatomic Shoulder AG e+ with Markers · Encore Medical L.P.510(k) · 2023-06-23
AETOS Shoulder System · Smith & Nephew, Inc.510(k) · 2023-06-07
AETOS Shoulder System · Smith & Nephew, Inc.510(k) · 2023-01-03
Catalyst EA Convertible Stemmed Shoulder · Catalyst Orthoscience, Inc.510(k) · 2022-11-10
AltiVate® Anatomic Shoulder AG e+ with Markers · Encore Medical L.P.510(k) · 2022-07-07
SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid · Limacorporate510(k) · 2022-05-13
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) · Smith & Nephew, Inc.510(k) · 2022-03-11
Exactech® Equinoxe® Laser Cage Glenoid · Exactech, Inc.510(k) · 2022-03-04
Comprehensive Humeral Fracture Positioning Sleeves · Biomet, Inc.510(k) · 2021-12-10
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) · Stryker GmbH510(k) · 2021-09-03
Augmented VaultLock Glenoid · Arthrex, Inc.510(k) · 2021-06-07
BLUEPRINT Patient Specific Instrumentation · Tornier S.A.S.510(k) · 2021-04-15
Global Shoulder and Delta CTA systems · Depuy Lnc.510(k) · 2021-04-02
AltiVate® Anatomic Pegged Glenoid with Markers · Encore Medical L.P.510(k) · 2020-12-23
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) · Stryker GmbH510(k) · 2020-12-16
Alliance Augmented Glenoid · Zimmer, Inc.510(k) · 2020-02-24
SmartSPACE Shoulder System · Techmah Medical, LLC510(k) · 2019-11-15
Alliance Glenoid · Zimmer, Inc.510(k) · 2019-10-23
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.