Chrysalis Intelligence · Product Codes · HSN

HSN · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Orthopedic · 28 clearances · 9 unique sponsors

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Device class
Class II
Regulation 888.3110
Total clearances
28
2020-01-29 → 2026-06-16
Last 12 months
1
Unique sponsors
9
Classification details
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3110
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
Paragon 28, Inc. 7 0 2025-05-01
Restor3D 5 0 2025-09-03
In2bones Sas 4 0 2024-04-23
Wright Medical Technology, Inc. (Stryker) 3 1 2026-06-16
Wrightmedicaltechnologyinc 3 0 2023-01-27
Vilex, LLC 2 0 2024-12-02
Exactech, Inc. 2 0 2023-10-12
Integra LifeSciences Corporation 1 0 2020-06-29
Kinos Medical 1 0 2020-06-30
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
27702 CPT — High Standard CPT for ankle arthroplasty, cemented
C1737 HCPCS Joint fusion and fixation device(s), sacroiliac and pelvis, including all system components (implantable) ✓ CMS-verified description Medium Prosthesis, ankle, metallic
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-16 K253159 Wright Medical Technology, Inc. (Stryker) Prophecy Incompass Surgical Planning System
2025-09-03 K252454 Restor3D Kinos Total Ankle System
2025-06-20 K250037 Wright Medical Technology, Inc. (Stryker) Incompass Total Ankle System
2025-05-01 K250641 Paragon 28, Inc. APEX 3D Total Ankle Replacement System
2024-12-02 K240475 Vilex, LLC Hintermann Series H2 Total Ankle System
2024-11-01 K241999 Wright Medical Technology, Inc. (Stryker) Prophecy Surgical Planning System
2024-10-18 K242868 Restor3D Kinos Total Ankle System
2024-07-22 K241482 Restor3D Kinos Total Ankle System
2024-06-24 K240259 Paragon 28, Inc. APEX 3D Total Ankle Replacement System
2024-04-29 K240591 Restor3D, Inc. restor3d Kinos Axiom Total Ankle System
2024-04-23 K231699 In2bones Sas QUANTUM® Patient Specific Instrumentation (PSI) System
2023-11-28 K232595 Restor3D Kinos Axiom Total Ankle System
2023-10-12 K230717 Exactech, Inc. Exactech® Vantage® Total Ankle System
2023-09-11 K232002 Exactech, Inc. Vantage® Total Ankle System
2023-07-17 K230462 Vilex, LLC OPTIX H2 Patient Specific Instrument System
2023-04-06 K230313 In2bones Sas QUANTUM Patient Specific Instrumentation (PSI) System
2023-01-27 K222835 Wrightmedicaltechnologyinc Prophecy Preoperative Navigation Alignment System
2022-11-17 K223227 Paragon 28, Inc. MAVEN™ Patient-Specific Instrumentation
2021-08-11 K211883 In2bones Sas QUANTUM® Patient Specific Instrumentation (PSI) System
2021-03-10 K202815 Wrightmedicaltechnologyinc PROPHECY Preoperative Navigation Alignment System
2021-03-06 K210390 Paragon 28, Inc. Apex 3D Total Ankle Replacement System
2021-01-14 K202019 Paragon 28, Inc. Maven Patient-Specific Instrumentation
2020-11-13 K202373 Paragon 28, Inc. APEX 3D Total Ankle Replacement System
2020-07-10 K192994 Paragon 28, Inc. Paragon 28 APEX 3D Total Ankle Replacement System
2020-06-30 K192778 Kinos Medical Kinos Axiom Total Ankle System
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence