Identity
- Trade Name
- HemiCAPITATETM FDA UDI
- Generic Name
- Carpal lunate prosthesis FDA UDI
- Device Name
- 15mm Capitate Component, 35mm x 17mm, Wrist FDA UDI
- Model / Reference
- 8W15-3517-A FDA UDI
- Description
- 15mm Capitate Component, 35mm x 17mm, Wrist FDA UDI
Identifiers
- Catalog Number
- 8W15-3517-A FDA UDI
- Primary DI / UDI-DI
- M5288W153517A0 FDA UDI
- 510(k) Number
- K141920 FDA UDI
- FDA Product Code
- KWN FDA UDI
- GMDN Term
- Carpal lunate prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carpal lunate prosthesis
HemiCAPITATETM by Arthrosurface Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carpal lunate prosthesis.
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc. · Class II
- PyroCarbon Lunate — Smith & Nephew, Inc. · Class II
- PyroCarbon Lunate — Smith & Nephew, Inc. · Class II
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc. · Class II
- PyroCarbon Lunate — Smith & Nephew, Inc. · Class II
- 3100B HFOV — VYAIRE MEDICAL, INC. · Class III
- Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Kit 1) — FLEXICARE MEDICAL LIMITED · Class II
- Ascension® PyroCarbon Lunate — Ascension Orthopedics, Inc. · Class II
Cleared under the same submission
K141920 also covers:
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- HemiCAPITATETM — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
- WristMotion® Wrist Hemiarthroplasty System — ARTHROSURFACE INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Arthrosurface Incorporated
Sources (1)
- FDA UDI e54be875-8f6c-4fa0-be36-ea1a877b6212 36 fields · synced Jun 6, 2026