Chrysalis Intelligence · Product Codes · JWH

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

Orthopedic · 128 clearances · 44 unique sponsors

Device class
Class II
Regulation 888.3560
Total clearances
128
2020-01-24 → 2026-08-07
Last 12 months
11
Unique sponsors
44
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3560
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
Conformis, Inc. 13 0 2023-07-17
Smith & Nephew, Inc. 9 0 2025-04-02
Maxx Orthopedics, Inc. 8 3 2026-08-07
Medacta International S.A. 7 0 2023-06-09
Corentec Co., Ltd. 7 0 2025-04-17
Zimmer, Inc. 7 0 2025-03-06
Depuy Ireland UC 6 2 2026-06-25
Encore Medical L.P. 4 1 2025-12-19
Howmedica Osteonics Corp., Dba Stryker Orthopaedics 4 0 2025-02-06
Total Joint Orthopedics, Inc. 4 1 2026-07-23
Signature Orthopaedics Pty, Ltd. 4 0 2024-09-11
B-One Ortho, Corp. 4 0 2022-10-06
United Orthopedic Corporation 4 1 2025-09-25
Lima Corporate S.P.A. 4 0 2024-01-18
Total Joint Othopedics, Inc. 3 0 2025-03-24
Waldemar Link GmbH & Co. KG 3 0 2023-03-21
Materialise NV 3 1 2026-01-06
Ortho Development Corporation 2 0 2024-10-25
Corin U.S.A. Limited 2 0 2024-09-23
Osteoremedies, LLC 2 0 2024-10-02
Globus Medical, Inc. 2 1 2026-07-31
Encore Medical, L.P Dba Enovis 2 0 2023-04-06
Meril Healthcare Pvt. , Ltd. 2 0 2022-11-18
Microport Orthopedics, Inc. 2 0 2025-02-18
Suzhou Microport Orthorecon Co., Ltd. 1 0 2025-02-28
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
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

DateK-numberSponsorDevice
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 System—PSA 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
2025-03-13 K250382 Maxx Orthopedics, Inc. Freedom Total Knee System (All-poly Tibial Plate)
2025-03-06 K243724 Zimmer, Inc. Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
2025-02-28 K244039 Suzhou Microport Orthorecon Co., Ltd. MedalOne Total Knee System
2025-02-18 K243574 Microport Orthopedics, Inc. Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
2025-02-06 K243817 Howmedica Osteonics Corp., Dba Stryker Orthopaedics Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert
2025-01-14 K241180 Shalby Advanced Technologies Consensus Knee System with TiNbN