Matryx Interference Screw, 239038T5, 231025T5, 231033T5, 231038T5, 231125T5, 231133T5, 231138T5
by Conmed Linvatec Biomaterials
510(k) K063588
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063588 | Date2 Mar 2007 | 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- Withdrawn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 Matryx Interference Screw is a bone fixation device classified under the FDA’s orthopedic category (Product Code HWC). Designed as an interference screw, it provides initial stability during bone healing by compressing bone fragments, promoting biological fixation and bone in-growth over time. These screws are intended for use in orthopedic procedures requiring secure fixation of soft tissue to bone, such as ligament reconstructions. Their threaded design ensures a tight fit within the bone, reducing micromotion and enhancing integration.
The Matryx Interference Screw is supplied in multiple sizes (239038T5, 231025T5, 231033T5, 231038T5, 231125T5, 231133T5, 231138T5) and is intended for single-use applications. It has received FDA clearance under a Traditional 510(k) pathway, classified as substantially equivalent to predicate devices. The device is not specified as sterile or reusable in the provided data, and no MRI safety information is included. Storage and handling instructions are not detailed beyond standard orthopedic implant protocols.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Matryx Interference Screw?
The Matryx Interference Screw is designed to provide initial stability during bone healing by compressing bone fragments together. This compression promotes biological fixation and encourages bone in-growth over time, making it ideal for orthopedic procedures such as ligament reconstructions. Its threaded design ensures a tight fit within the bone, reducing micromotion and enhancing integration between soft tissue and bone.
Are these screws single-use or reusable?
The Matryx Interference Screw is intended for single-use applications only. This is a standard practice for orthopedic fixation devices to ensure patient safety and sterility, as reuse could compromise integrity and introduce infection risks.
What sizes are available for the Matryx Interference Screw?
The Matryx Interference Screw comes in multiple sizes, specifically the following reference numbers: 239038T5, 231025T5, 231033T5, 231038T5, 231125T5, 231133T5, and 231138T5. These variations allow clinicians to select the appropriate size for their specific orthopedic procedure.
Is the Matryx Interference Screw sterile?
The provided data does not explicitly state whether the Matryx Interference Screw is sterile or not. Typically, orthopedic implants like this are supplied sterile to prevent infection, but it is always best to confirm with the manufacturer or packaging instructions before use.
What regulatory pathway was followed for FDA clearance of this device?
The Matryx Interference Screw received FDA clearance through the Traditional 510(k) pathway, which determines that it is substantially equivalent to predicate devices already on the market. This classification falls under the orthopedic category (Product Code HWC) and was reviewed by the Orthopedic (OR) Advisory Committee.