Chrysalis Intelligence · Product Codes · JWH

JWH · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Orthopedic · 134 clearances · 47 unique sponsors

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Device class

Class II

Regulation 888.3560

Total clearances

134

2020-01-24 → 2026-09-15

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3560

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
Conformis, Inc.	13	0	2023-07-17
Smith & Nephew, Inc.	9	0	2025-04-02
Maxx Orthopedics, Inc.	8	3	2026-08-07
Zimmer, Inc.	7	0	2025-03-06
Medacta International S.A.	7	0	2023-06-09
Corentec Co., Ltd.	7	0	2025-04-17
Depuy Ireland UC	6	2	2026-06-25
B-One Ortho, Corp.	5	1	2026-09-08
Total Joint Orthopedics, Inc.	4	1	2026-07-23
United Orthopedic Corporation	4	0	2025-09-25
Encore Medical L.P.	4	1	2025-12-19
Howmedica Osteonics Corp., Dba Stryker Orthopaedics	4	0	2025-02-06
Lima Corporate S.P.A.	4	0	2024-01-18
Signature Orthopaedics Pty, Ltd.	4	0	2024-09-11
Materialise NV	3	1	2026-01-06
Waldemar Link GmbH & Co. KG	3	0	2023-03-21
Total Joint Othopedics, Inc.	3	0	2025-03-24
Corin U.S.A. Limited	2	0	2024-09-23
Encore Medical, L.P Dba Enovis	2	0	2023-04-06
DePuy Orthopaedics, Inc.	2	1	2026-09-04
Osteoremedies, LLC	2	0	2024-10-02
Globus Medical, Inc.	2	1	2026-07-31
Microport Orthopedics, Inc.	2	0	2025-02-18
Suzhou Microport Orthorecon Co., Ltd.	2	1	2026-09-10
Meril Healthcare Pvt. , Ltd.	2	0	2022-11-18

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
27447	CPT	—	High	CPT code for knee prosthesis, cemented, patellofemoral and tibiofemoral components
L5858	HCPCS	Addition to lower extremity prosthesis, endoskeletal knee shin system, microprocessor control feature, stance phase only, includes electronic sensor(s), any type ✓ CMS-verified description	Medium	HCPCS code for prosthetic knee components and supplies

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-15	K262057	Medacta International SA	GMK Extension
2026-09-11	K260063	The General Hospital Corporation, d/b/a Massachusetts	GSPE Spacer
2026-09-10	K262293	Suzhou Microport Orthorecon Co., Ltd.	EVOLUTION MPX Total Knee System
2026-09-08	K262341	B-One Ortho, Corp.	b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
2026-09-04	K262130	Depuy Orthopaedics, Inc.	ATTUNE Revision Knee System
2026-09-01	K253961	Just Medical Devices (Tianjin) Co., Ltd.	SK Knee System
2026-08-07	K261563	Maxx Orthopedics, Inc.	Freedom Total Knee System (E-Poly Tibial Liners)
2026-07-31	K262251	Globus Medical, Inc.	ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
2026-07-23	K261734	Total Joint Orthopedics, Inc.	Klassic Infection Spacer System
2026-06-25	K261458	DePuy Ireland UC	ATTUNE Total Knee System; ATTUNE Cementless Knee System
2026-04-27	K261032	NovoSource	NovoKnee (SteriKnee)
2026-01-06	K253793	Materialise NV	Materialise TKA Guide System
2025-12-19	K252974	Encore Medical L.P.	EMPOWR Knee
2025-11-19	K253197	Depuy Ireland UC	ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
2025-10-29	K253314	Maxx Orthopedics, Inc.	Freedom Infinia Total Knee System
2025-10-22	K253144	Maxx Orthopedics, Inc.	Freedom® Total Knee System Titan PCK Components
2025-09-25	K252725	United Orthopedic Corporation	Stem Extension Line (U2 Total Knee SystemPSA Type)
2025-07-14	K251554	Materialise NV	Materialise TKA Guide System
2025-07-08	K251776	Encore Medical L.P.	EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
2025-07-02	K251241	Encore Medical L.P.	EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)
2025-06-26	K251717	Maxx Orthopedics, Inc.	Freedom® Total Knee System Titanium Tibial Base Plate
2025-05-08	K242410	Nextstep Arthropedix	NextStep Arthropedix Total Knee System
2025-04-17	K250889	Corentec Co., Ltd.	EXULT Knee Replacement System
2025-04-02	K250677	Smith & Nephew, Inc.	LEGION Total Knee System
2025-03-24	K243991	Total Joint Othopedics, Inc.	Klassic Knee System - Revision Tibial Baseplate