Chrysalis Intelligence · Product Codes · OYK

OYK · Ankle Arthroplasty Implantation System

Orthopedic · 7 clearances · 2 unique sponsors

Device class
Class II
Regulation 888.3110
Total clearances
7
2020-11-09 → 2024-10-25
Last 12 months
0
Unique sponsors
2
Definition

What is Ankle Arthroplasty Implantation System

Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3110
Implant
N
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
3D Systems, Inc. 6 0 2024-10-25
Restor3D 1 0 2023-03-30
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
20610 CPT Medium Arthrocentesis/ankle joint procedure code; instrument guides for orthopedic procedures often billed with procedural codes
27700 CPT Medium Ankle arthroplasty procedure code; implantation system guides typically included in surgical procedure billing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-10-25 K243174 3D Systems, Inc. Cadence Ankle PSI System
2024-10-25 K243173 3D Systems, Inc. Salto Talaris Ankle PSI System
2024-08-30 K241326 3D Systems, Inc. Cadence Ankle PSI System
2024-08-30 K241148 3D Systems, Inc. Salto Talaris Ankle PSI System
2023-06-30 K231585 3D Systems, Inc. Vantage PSI System
2023-03-30 K223326 Restor3D Axiom PSR System
2020-11-09 K193432 3D Systems Vantage PSI System