PHX · Shoulder Prosthesis, Reverse Configuration

Device class

Class II

Regulation 888.3660

Total clearances

2020-01-10 → 2026-07-01

Last 12 months

Unique sponsors

Definition

What is Shoulder Prosthesis, Reverse Configuration

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3660

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Fx Shoulder USA, Inc.	8	0	2024-05-15
Medacta International S.A.	7	2	2026-02-03
Depuy Ireland UC	7	1	2026-03-11
FH Industrie	6	3	2026-01-09
Catalyst Orthoscience, Inc.	6	0	2024-04-05
Lima Corporate S.P.A.	5	1	2026-01-22
Exactech, Inc.	5	1	2026-04-14
Arthrex, Inc.	5	0	2023-04-10
Encore Medical L.P.	4	1	2026-01-15
Tornier, Inc.	4	1	2026-01-08
Shoulder Innovations, Inc.	4	3	2026-04-13
Restor3D	3	2	2026-07-01
Waldemar Link GmbH & Co. KG	3	0	2023-11-16
Biomet Manufacturing Corp	3	0	2023-03-15
Fix Surgical	2	0	2024-05-15
Stryker Corporation (Tornier, S.A.S.)	2	1	2026-04-03
Zimmer GmbH	2	1	2026-06-16
Medacta International, SA	1	1	2026-06-10
Biomet, Inc.	1	0	2020-04-15
DePuy Orthopaedics, Inc.	1	0	2021-02-19
Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.	1	0	2021-08-04
Tornier S.A.S.	1	0	2024-02-21
Medacta Inernational SA	1	0	2020-08-11
Depuy(Ireland)	1	0	2020-02-24
Stryker Corporation (Tornier, Inc.)	1	1	2026-06-12

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.

Code	Type	Description	Confidence	Rationale
23472	CPT	—	High	Standard CPT for reverse total shoulder arthroplasty (RTSA) procedure
23473	CPT	—	High	Reverse total shoulder arthroplasty with glenoid and humeral component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-01	K260556	Restor3D	Veritas Shoulder System
2026-06-16	K261683	Zimmer, Inc.	Augment Off-Axis Instrument System
2026-06-12	K260102	Stryker Corporation (Tornier, Inc.)	Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
2026-06-10	K261016	Medacta International, SA	MSS - Humeral reverse liners extension
2026-05-07	K253992	Restor3D	Veritas Reverse Total Shoulder System
2026-04-15	K252404	Biomet Orthopedics	Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
2026-04-14	K260583	Exactech, Inc.	Equinoxe® Shoulder System
2026-04-13	K254128	Shoulder Innovations, Inc.	InSet Reverse Total Shoulder System
2026-04-03	K253674	Stryker Corporation (Tornier, S.A.S.)	Blueprint Patient-Specific Instrumentation
2026-03-11	K253624	Depuy Ireland UC	INHANCE Reverse Shoulder System
2026-02-03	K250644	Medacta International S.A.	MSS - Monobloc stem
2026-01-22	K252352	Lima Corporate S.P.A.	SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
2026-01-15	K252567	Encore Medical L.P.	AltiVate Reverse® ADLC Glenosphere
2026-01-15	K252516	Shoulder Innovations, Inc.	N22 EZ Glenosphere
2026-01-09	K254003	FH Industrie	JARVIS Metaphyseal Stem
2026-01-08	K252788	Tornier, Inc.	Tornier Perform Reversed Monopost Glenoid (Perform Mono)
2025-10-31	K250338	Medacta International S.A.	MSS - Humeral reverse liners extension
2025-10-29	K253345	FH Industrie	JARVIS Diaphyseal Stem Standard
2025-09-26	K252221	Shoulder Innovations, Inc.	Inset Reverse Total Shoulder System
2025-08-28	K252411	FH Industrie	JARVIS Glenoid Reverse Shoulder Prosthesis
2025-08-05	K252141	Encore Medical L.P.	AltiVate Reverse® Glenoid
2025-08-01	K243448	Exactech, Inc.	Equinoxe® Shoulder System
2025-07-03	K243826	Lima Corporate S.P.A.	SMR Reverse HP Shoulder System
2025-05-19	K243643	Restor3D	restor3d Reverse Total Shoulder Arthroplasty System
2025-05-16	K251184	Encore Medical L.P.	AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System