MBH · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Device class

Class II

Regulation 888.3565

Total clearances

2020-03-18 → 2026-05-28

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3565

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
Zimmer, Inc.	6	2	2026-05-28
Depuy Ireland UC	6	0	2024-06-18
Lima Corporate S.P.A.	4	0	2025-05-22
Optimotion Implants, LLC	3	0	2024-06-27
Medacta International S.A.	3	1	2026-02-26
Smith & Nephew, Inc.	3	0	2021-10-01
Maxx Orthopedics, Inc.	2	1	2025-10-31
Waldemar Link GmbH & Co. KG	2	0	2020-07-17
Microport Orthopedics, Inc.	2	0	2024-01-18
United Orthopedic Corporation	2	0	2025-07-31
Conformis, Inc.	2	0	2023-09-08
Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2	2	2026-02-18
Encore Medical L.P.	1	0	2021-03-30
Zimmer Biomet	1	0	2024-12-20
Ortho Development Corp.	1	1	2025-12-19
Restor3D, Inc.	1	0	2025-03-27
Medisurge, LLC	1	0	2024-11-06
Unik Orthopedics, Inc.	1	0	2020-08-12
Exactech, Inc.	1	0	2024-10-03
Encore Medical, L.P. Dba Djo Surgical	1	0	2022-01-20
Signature Orthopaedics Pty, Ltd.	1	1	2025-12-23
Signal Medical Corporation	1	0	2021-06-10
Howmedica Osteonics Corp.	1	0	2020-05-13

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 for total knee arthroplasty with prosthesis; standard code for knee prosthesis implantation
L5200	HCPCS	Above knee, molded socket, single axis constant friction knee, shin, sach foot ✓ CMS-verified description	Medium	HCPCS prosthetic knee component code, alternative billing approach

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-28	K251840	Zimmer, Inc.	Zimmer® Persona® Personalized Knee System
2026-03-09	K253189	Zimmer, Inc.	Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
2026-02-26	K253328	Medacta International S.A.	GMK 3D Metal Tibial Tray Extension
2026-02-18	K253637	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
2025-12-23	K253239	Signature Orthopaedics Pty, Ltd.	Active-V Total Knee System; World Total Knee System
2025-12-19	K253161	Ortho Development Corp.	Balanced Knee System TriMax Porous Femoral Components
2025-10-31	K252777	Maxx Orthopedics, Inc.	Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
2025-10-24	K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components
2025-07-31	K243656	United Orthopedic Corporation	U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella
2025-05-22	K250980	Lima Corporate S.P.A.	Physica System (Physica CR Porous Femoral components)
2025-03-27	K243768	Restor3D, Inc.	iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
2025-02-13	K241597	Maxx Orthopedics, Inc.	Freedom® Total Knee System - Porous Tibial Base Plate
2024-12-20	K243293	Zimmer Biomet	Zimmer® Persona® Personalized Knee System
2024-12-18	K243615	Lima Corporate S.P.A.	Physica Porous Femoral Components
2024-11-22	K242543	Zimmer, Inc.	Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)
2024-11-06	K242412	Medisurge, LLC	Agility Symmetric Total Knee System
2024-10-29	K243247	Zimmer, Inc.	Persona the Personalized Knee System
2024-10-03	K240393	Exactech, Inc.	Exactech® TRULIANT® Knee System
2024-06-27	K240938	Optimotion Implants, LLC	The Optimotion Blue Plus Knee System
2024-06-18	K240678	Depuy Ireland UC	ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
2024-04-26	K240299	Zimmer, Inc.	Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
2024-01-18	K233507	Microport Orthopedics, Inc.	EVOLUTION® Tibial Cones
2023-12-11	K232303	Depuy Ireland UC	ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
2023-09-08	K232426	Conformis, Inc.	Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
2023-07-21	K223316	Conformis, Inc.	Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System