Chrysalis Intelligence · Product Codes · KWS

KWS · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Orthopedic · 24 clearances · 14 unique sponsors

Device class
Class II
Regulation 888.3660
Total clearances
24
2020-02-24 → 2026-07-22
Last 12 months
4
Unique sponsors
14
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3660
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Smith & Nephew, Inc. 5 2 2026-04-06
Encore Medical L.P. 3 0 2023-06-23
Arthrex, Inc. 2 0 2023-09-26
Stryker Corporation (Tornier, Inc.) 2 0 2024-12-06
Catalyst Orthoscience, Inc. 2 1 2025-11-06
Stryker GmbH 2 0 2021-09-03
Depuy Lnc. 1 0 2021-04-02
Limacorporate 1 0 2022-05-13
Biomet, Inc. 1 0 2021-12-10
Zimmer, Inc. 1 0 2020-02-24
Medacta International S.A. 1 0 2025-01-30
Tornier S.A.S. 1 0 2021-04-15
Exactech, Inc. 1 0 2022-03-04
Tornier, Inc. 1 1 2026-07-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
23472 CPT High Standard CPT for shoulder prosthesis implantation, semi-constrained
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-22 K260721 Tornier, Inc. Tornier Perform Advanced Glenoid
2026-04-06 K254084 Smith & Nephew, Inc. AETOS Shoulder System - CONCELOC Glenoids
2025-11-06 K252418 Catalyst Orthoscience, Inc. Catalyst F1x Shoulder System
2025-10-29 K252416 Smith & Nephew, Inc. AETOS Shoulder System Meta Humeral Prosthesis Size 0
2025-01-30 K241292 Medacta International S.A. MyShoulder Planner (5.3SSWPL)
2024-12-06 K241878 Stryker Corporation (Tornier, Inc.) Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
2024-09-10 K241609 Stryker Corporation (Tornier, Inc.) Tornier Humeral Reconstruction System (Tornier HRS)
2023-09-26 K230513 Arthrex, Inc. Arthrex Univers Apex OptiFit Humeral Stem
2023-06-23 K222592 Encore Medical L.P. AltiVate® Anatomic Shoulder AG e+™ with Markers
2023-06-07 K230572 Smith & Nephew, Inc. AETOS Shoulder System
2023-01-03 K220847 Smith & Nephew, Inc. AETOS Shoulder System
2022-11-10 K222317 Catalyst Orthoscience, Inc. Catalyst EA Convertible Stemmed Shoulder
2022-07-07 K213387 Encore Medical L.P. AltiVate® Anatomic Shoulder AG e+™ with Markers
2022-05-13 K213785 Limacorporate SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
2022-03-11 K213827 Smith & Nephew, Inc. 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)
2022-03-04 K212356 Exactech, Inc. Exactech® Equinoxe® Laser Cage Glenoid
2021-12-10 K212435 Biomet, Inc. Comprehensive Humeral Fracture Positioning Sleeves
2021-09-03 K210861 Stryker GmbH ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
2021-06-07 K210050 Arthrex, Inc. Augmented VaultLock Glenoid
2021-04-15 K203315 Tornier S.A.S. BLUEPRINT™ Patient Specific Instrumentation
2021-04-02 K203230 Depuy Lnc. Global Shoulder and Delta CTA systems
2020-12-23 K203026 Encore Medical L.P. AltiVate® Anatomic Pegged Glenoid with Markers
2020-12-16 K202289 Stryker GmbH ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
2020-02-24 K193180 Zimmer, Inc. Alliance Augmented Glenoid