Braun-Cutter Trapezo-Metacarpal Prosthesis
PMA P960053
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP960053 | Date19 Jun 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Sbi Braun-Cutter Trapez-Metacarpal Prosthesis
- Trade Name
- Braun-Cutter Trapezo-Metacarpal Prosthesis
- Generic Name
- Prosthesis, finger, constrained, metal/polymer
- PMA Number
- FDA Product Code
- KWG
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3220
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Braun-Cutter Trapezo-Metacarpal Prosthesis is a constrained metal/polymer finger prosthesis designed for total joint replacement. It is classified as a Prosthesis, Finger, Constrained, Metal/Polymer and is intended for use in skeletally mature patients requiring joint stabilization due to degenerative, inflammatory, or traumatic conditions, or as a revision following prior procedures.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is approved under FDA PMA (P960053) and falls under device classification KWG, regulation number 888.3220. The prosthesis is available in specific sizes as detailed in the approved specifications, with compliance ensured through regulatory submission to the FDA.
Other devices from Stryker Corp.
Questions
AI-generated answers, 18 Sep 2026
What specific conditions is the Braun-Cutter Trapezo-Metacarpal Prosthesis approved to address in patients?
This prosthesis is approved for use in skeletally mature patients experiencing pain or instability in the trapezo-metacarpal joint due to degenerative diseases (like osteoarthritis), inflammatory conditions (such as rheumatoid arthritis), or traumatic injuries. It is also indicated for revision cases following prior procedures, offering an alternative to arthrodesis or reconstructive surgery when joint stabilization is needed.
Is the Braun-Cutter Trapezo-Metacarpal Prosthesis reusable or intended for single-use, and how is it supplied?
The device is explicitly intended for **single-use** in orthopedic surgical settings. It is supplied **sterile**, ensuring readiness for immediate implantation without requiring additional sterilization steps.
What types of materials are used in the construction of this prosthesis, and how does that affect its function?
The prosthesis combines **metal and polymer materials**, which together provide constrained articulation for joint stabilization. The constrained design helps reduce dislocation risk while maintaining controlled movement, making it suitable for patients requiring joint replacement due to instability from degenerative, inflammatory, or traumatic conditions.
How do I determine the correct size for a patient when selecting this prosthesis?
The prosthesis is available in **specific sizes** as outlined in the approved specifications. Sizing should be based on preoperative measurements and anatomical assessment of the trapezo-metacarpal joint, ensuring proper fit and function. Exact sizing details are documented in the approved technical documentation submitted to the FDA.
What regulatory pathway was followed for this device’s approval, and how does that impact its use?
The Braun-Cutter Trapezo-Metacarpal Prosthesis was approved via the **FDA’s Premarket Approval (PMA) process**, specifically under PMA number **P960053**. This pathway ensures rigorous evaluation of safety and effectiveness for high-risk devices like constrained joint prostheses. Clinicians should refer to the approved labeling for precise indications and surgical guidelines.