Chrysalis Intelligence · Product Codes · HSX

HSX · Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Orthopedic · 23 clearances · 17 unique sponsors

Device class
Class II
Regulation 888.3520
Total clearances
23
2020-03-17 → 2026-04-02
Last 12 months
2
Unique sponsors
17
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3520
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
Bodycad Laboratories, Inc. 3 0 2021-10-12
Medacta International S.A. 2 0 2025-07-24
Smith & Nephew, Inc. 2 0 2024-10-30
Arthrex, Inc. 2 0 2025-07-01
Signature Orthopaedics Pty, Ltd. 2 1 2025-12-16
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 1 0 2020-10-27
Zimmer, Inc. 1 0 2020-03-17
Mako Surgical Corp. 1 0 2022-06-02
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics 1 1 2026-04-02
Overture Orthopaedics 1 0 2024-10-07
Overture Resurfacing, Inc. 1 0 2023-03-10
Kyocera Medical Technologies, Inc. 1 0 2024-04-04
Zimmer Biomet 1 0 2025-08-15
Materialise NV 1 0 2020-10-02
Globus Medical, Inc. 1 0 2024-12-06
Ortho Development Corporation 1 0 2021-12-16
Implantcast GmbH 1 0 2021-01-08
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 Standard CPT for knee arthroplasty, cemented, non-constrained
C1714 HCPCS Catheter, transluminal atherectomy, directional ✓ CMS-verified description Medium Prosthesis, knee, metallic/polymer
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-02 K260796 Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Tahoe Unicondylar Knee System with TiNbN Overcoat
2025-12-16 K251771 Signature Orthopaedics Pty, Ltd. Cambridge Partial Knee
2025-08-15 K251834 Zimmer Biomet Persona Partial Knee
2025-07-24 K251618 Medacta International S.A. MOTO Partial Knee System Extension
2025-07-01 K251453 Arthrex, Inc. Arthrex iBalance Partial Knee System
2024-12-06 K241260 Globus Medical, Inc. ACTIFY™ Unicondylar Knee System
2024-10-30 K242711 Smith & Nephew, Inc. JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
2024-10-07 K242746 Overture Orthopaedics OvertureTi Knee Resurfacing SystemTM
2024-04-04 K232114 Kyocera Medical Technologies, Inc. TRIBRID® Unicompartmental Knee System
2023-03-10 K221292 Overture Resurfacing, Inc. Uni Knee Resurfacing System
2022-06-16 K212870 Signature Orthopaedics Pty, Ltd. TLC Unicompartmental Knee System
2022-06-02 K220930 Mako Surgical Corp. Restoris Multi-Compartmental Knee System
2021-12-16 K211471 Ortho Development Corporation Balanced Knee System Uni
2021-11-16 K213071 Medacta International S.A. MOTOTM Partial Knee & MOTO PFJ Systems Extension
2021-10-12 K212307 Bodycad Laboratories, Inc. BC Reflex Uni Knee System
2021-09-16 K211512 Smith & Nephew, Inc. VISIONAIRE UK Patient Matched Cutting Guides
2021-08-20 K211895 Bodycad Laboratories, Inc. BC Reflex Uni Knee System
2021-03-12 K203697 Bodycad Laboratories, Inc. BC Reflex Uni Knee System
2021-01-08 K203341 Implantcast GmbH ACS LD Uni FB Knee System
2020-10-27 K203099 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Triathlon PKR System
2020-10-02 K202207 Materialise NV Materialise PKA Guide System
2020-03-17 K200433 Arthrex, Inc. iBalance UKA Tibial Tray Implant
2020-03-17 K200151 Zimmer, Inc. Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill