Chrysalis Intelligence · Product Codes · KRO

KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Orthopedic · 16 clearances · 9 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Device class

Class II

Regulation 888.3510

Total clearances

16

2020-12-10 → 2026-08-06

Last 12 months

2

Unique sponsors

9

Classification details

Medical specialty

Orthopedic

Review panel

OR

Regulation number

888.3510

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
Howmedica Osteonics Corp., Dba Stryker Orthopaedics	5	2	2026-08-06
Waldemar Link GmbH & Co. KG	2	0	2022-05-03
Microport Orthopedics, Inc.	2	0	2024-04-01
Depuy Ireland UC	2	0	2024-11-21
United Orthopedic Corporation	1	0	2025-08-22
Onkos Surgical	1	0	2021-07-28
Stryker	1	0	2023-05-19
Medacta International S.A.	1	0	2021-03-02
Zimmer, Inc.	1	0	2020-12-10

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	Total knee arthroplasty with or without distal femoral and proximal tibial augmentation
L8658	HCPCS	Interphalangeal joint spacer, silicone or equal, each ✓ CMS-verified description	Medium	Knee replacement; constrained prosthesis (hinged)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-06	K261898	Howmedica Osteonics Corp. dba Stryker Orthopaedics	Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
2025-12-15	K252898	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
2025-08-22	K252303	United Orthopedic Corporation	Stem Extension Line (USTAR II System)
2025-07-25	K251665	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Hinge Knee System
2024-11-21	K242871	Depuy Ireland UC	ATTUNE Revision Hinge Knee
2024-04-01	K240043	Microport Orthopedics, Inc.	EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
2024-03-21	K233980	Depuy Ireland UC	ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
2023-09-27	K230563	Microport Orthopedics, Inc.	EVOLUTION® Hinge Knee System
2023-05-19	K230416	Stryker	Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
2023-04-21	K223069	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Modular Rotating Hinge Knee Systems and Compatible Components
2023-01-20	K223528	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Hinge Knee System
2022-05-03	K220628	Waldemar Link GmbH & Co. KG	LINK Endo-Model EVO Knee System
2021-07-28	K211677	Onkos Surgical	ELEOS Limb Salvage System
2021-06-30	K211768	Waldemar Link GmbH & Co. KG	LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
2021-03-02	K210010	Medacta International S.A.	GMK Revision & Hinge Extension - TiNbN Coating
2020-12-10	K192798	Zimmer, Inc.	Zimmer Segmental System