Identity
- Trade Name
- Ascension® Silicone PIP FDA UDI
- Generic Name
- Proximal interphalangeal joint prosthesis, modular FDA UDI
- Device Name
- The Ascension silicone PIP is an anatomically designed, single use, one piece, flexible hinge prosthesis designed to be implanted without bone cement across the proximal interphalangeal (PIP) joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the prosthesis are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. the PIP provides 90 degrees of flexion from full extension. The Ascension PIP finger joint prostheses is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. FDA UDI
- Model / Reference
- SPIP5201WW FDA UDI
- Description
- The Ascension silicone PIP is an anatomically designed, single use, one piece, flexible hinge prosthesis designed to be implanted without bone cement across the proximal interphalangeal (PIP) joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the prosthesis are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. the PIP provides 90 degrees of flexion from full extension. The Ascension PIP finger joint prostheses is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. FDA UDI
Identifiers
- Catalog Number
- SPIP-520-1-WW FDA UDI
- Primary DI / UDI-DI
- 10381780116301 FDA UDI
- 510(k) Number
- K082231 FDA UDI
- FDA Product Code
- KYJ FDA UDI
- GMDN Term
- Proximal interphalangeal joint prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3230 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
No
FDA UDI
Category: Proximal interphalangeal joint prosthesis, modular
Ascension® Silicone PIP by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Proximal interphalangeal joint prosthesis, modular.
- SR PIP — Stryker Corp. · Unclassified
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Unclassified
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Unclassified
- SR PIP — Stryker Corp. · Unclassified
- SR PIP — Stryker Corp. · Unclassified
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Unclassified
- SR PIP — Stryker Corp. · Unclassified
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Unclassified
Cleared under the same submission
K082231 also covers:
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI aebe4a73-93a1-40cc-b3a3-98e59de39b88 38 fields · synced May 30, 2026