One-Piece PEEK Fusion Implant
510(k) K140970
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140970 | Date13 May 2014 | 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- Withdrawn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
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The One-Piece PEEK Fusion Implant is a bone fixation device classified as an orthopedic implant for spinal or skeletal fusion procedures. Constructed from polyetheretherketone (PEEK), this implant is designed to stabilize osteotomies and facilitate bone union in reconstructive surgeries, particularly for lesser toe deformities such as hammertoe, claw toe, or mallet toe. Its single-piece design ensures secure fixation without modular components, promoting consistent alignment and healing.
This implant is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K140970) as substantially equivalent to predicate devices, adhering to orthopedic fixation standards. Available in predefined sizes for lesser toe reconstruction, it requires proper surgical technique for implantation and is not intended for MRI use due to PEEK’s non-metallic composition. Storage follows standard sterile orthopedic implant protocols.
Other devices from Mtp Solutions, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the One-Piece PEEK Fusion Implant used for?
This implant is designed specifically for spinal or skeletal fusion procedures, particularly in reconstructive surgeries for lesser toe deformities such as hammertoe, claw toe, or mallet toe. Its purpose is to stabilize osteotomies and promote proper bone alignment and union during the healing process. The single-piece PEEK construction ensures consistent fixation without the variability introduced by modular components.
How is the One-Piece PEEK Fusion Implant supplied and prepared for use?
The implant is supplied as a sterile, single-use device, meaning it is pre-packaged and intended for one-time surgical use only. This ensures safety and sterility, reducing the risk of contamination or cross-infection. Clinicians must follow standard sterile orthopedic implant protocols for handling and preparation before use in surgery.
Is the One-Piece PEEK Fusion Implant reusable or intended for single-use?
The implant is explicitly designed for single-use only. This is a standard practice for orthopedic implants to maintain sterility and safety, as reuse could compromise the integrity of the device and introduce infection risks. Always adhere to the manufacturer’s guidelines for proper disposal after a single surgical procedure.
What sizes are available for the One-Piece PEEK Fusion Implant?
The implant comes in predefined sizes tailored for lesser toe reconstruction. Exact sizing details should be referenced in the product documentation provided by Mtp Solutions, LLC, as these are critical for achieving proper fit and fixation during surgery. Always verify the correct size matches the patient’s anatomy before use.
Can the One-Piece PEEK Fusion Implant be used in MRI scans?
No, this implant is not intended for MRI use. Since it is made from polyetheretherketone (PEEK), a non-metallic material, it does not contain ferromagnetic components that could interfere with MRI imaging. However, clinicians should still confirm compatibility with their specific MRI protocols and equipment to avoid any potential risks.