Chrysalis Intelligence · Product Codes · PKC

PKC · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Orthopedic · 15 clearances · 13 unique sponsors

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Device class

Class II

Regulation 888.3660

Total clearances

2020-04-29 → 2026-05-01

Last 12 months

Unique sponsors

Definition

What is Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Replacement of the humeral head for total anatomic shoulder arthroplasty

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
Smith & Nephew, Inc.	2	1	2025-10-03
Arthrex, Inc.	2	0	2020-11-20
Ignite Orthopedics, LLC	1	0	2021-07-16
Zimmer, Inc.	1	0	2024-12-11
Lima Corporate S.P.A.	1	0	2023-03-17
Shoulder Innovations, Inc.	1	0	2022-03-11
Tornier, Inc.	1	0	2022-09-14
Exactech, Inc.	1	0	2020-04-29
Depuy Ireland UC	1	0	2024-12-23
Depuy(Ireland)	1	0	2022-01-19
Fx Shoulder USA, Inc.	1	0	2021-02-16
FX Shoulder Solutions, Inc.	1	1	2026-05-01
Encore Medical L.P.	1	0	2020-06-03

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 total anatomic shoulder arthroplasty with humeral stem
23470	CPT	—	Medium	Total shoulder arthroplasty (anatomic variant covered under primary code)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-01	K254154	FX Shoulder Solutions, Inc.	FX V135 EASYTECH® Shoulder System
2025-10-03	K252129	Smith & Nephew, Inc.	AETOS Shoulder System Stemless Humeral Prosthesis
2024-12-23	K243248	Depuy Ireland UC	INHANCE INTACT
2024-12-11	K241873	Zimmer, Inc.	OsseoFit Stemless Shoulder System
2024-11-20	K240716	Smith & Nephew, Inc.	AETOS Shoulder System Stemless Humeral Prosthesis
2023-03-17	K221758	Lima Corporate S.P.A.	SMR Stemless Anatomic
2022-09-14	K220418	Tornier, Inc.	Tornier Perform Humeral System Stemless
2022-03-11	K213615	Shoulder Innovations, Inc.	Shoulder Innovations Total Shoulder System
2022-01-19	K212683	Depuy(Ireland)	GLOBAL ICON Stemless Shoulder System
2021-07-16	K203108	Ignite Orthopedics, LLC	Ignite Stemless Anatomic Shoulder System
2021-02-16	K201391	Fx Shoulder USA, Inc.	Easytech® Anatomical Shoulder System
2020-11-20	K203100	Arthrex, Inc.	Arthrex Eclipse Titanium Humeral Head
2020-07-08	K201542	Arthrex, Inc.	Arthrex Eclipse Shoulder Prosthesis System
2020-06-03	K193226	Encore Medical L.P.	AltiVate Anatomic Canal-Sparing (CS) Shoulder
2020-04-29	K192097	Exactech, Inc.	Exactech® Equinoxe® Stemless Humeral Components