Tyber Medical Wedge System
by Tyber Medical, LLC 2 variants
510(k) K171327
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171327 | Date16 May 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PLF
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tyber Medical Wedge System is a Class II bone wedge device designed for internal fixation in orthopedic procedures. It is intended for use in opening wedge osteotomies of the ankle and foot, including corrections for conditions such as Hallux Valgus. Constructed as a surgical implant, it provides structural support during bone realignment and stabilization.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K171327) as a Special submission under the Orthopedic Advisory Committee. The system is categorized under product code PLF and regulation number 888.3030, adhering to orthopedic surgical standards. Storage and handling should follow manufacturer guidelines to maintain sterility and device integrity.
Other devices from Tyber Medical
Questions
AI-generated answers, 1 Oct 2026
What is the Tyber Medical Wedge System used for?
The Tyber Medical Wedge System is designed for internal fixation during opening wedge osteotomies of the ankle and foot. It provides structural support to realign and stabilize bones, particularly for conditions like Hallux Valgus, where surgical correction of joint deformities is required. The device is intended to maintain proper alignment post-surgery while the bone heals.
Is the Tyber Medical Wedge System sterile and single-use?
Yes, the Tyber Medical Wedge System is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining device integrity. Single-use also aligns with best practices for orthopedic implants to minimize infection risks.
How should the Tyber Medical Wedge System be stored?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and structural integrity. Proper storage typically involves keeping it in its original packaging, away from direct sunlight, extreme temperatures, and moisture. Follow the instructions provided by Tyber Medical to ensure the device remains effective for its intended use.
What regulatory approval does the Tyber Medical Wedge System hold?
The Tyber Medical Wedge System holds FDA 510(k) clearance under the reference number K171327. This clearance was granted as a Special submission under the Orthopedic Advisory Committee, confirming its substantial equivalence to a predicate device. The product is classified under FDA product code PLF and regulation number 888.3030.
Are there different sizes or models available for the Tyber Medical Wedge System?
The specifications provided do not explicitly list individual sizes or models, but the system is designed to accommodate various osteotomy procedures in the ankle and foot. For precise sizing and selection, refer to the manufacturer’s technical documentation or consult with a surgical specialist. Tyber Medical likely offers multiple wedge configurations to match specific clinical needs.