# K063588: Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec Biomaterials
- Decided: Mar 2, 2007 after 92 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933738 (1994). 31 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933719: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1994) Summary page 1.
- K952831: Bioscrew Absorbable Interference Screw, Linvatec Corp. (1995) Summary page 1.
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 1.
- K052080: Matryx Interference Screw, Linvatec Biomaterials, Inc. (2005) Summary page 1.

## Most influential descendants
- K071437: Megafix-C  Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C (2007), 1 descendant of its own
- K203335: MectaScrew Extension (2022), 0 descendants of its own
- K092998: Conmed Linvatec Intercept Implant (2009), 0 descendants of its own

## Indications for use
The MatryxTM Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The MatryxTM Interference Screw is not intended for use in and is contraindicated for 1) Insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitations and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs which would not be appropriate for fixation with metallic screws

Source page: https://510kreport.com/device/K063588
Methodology: https://510kreport.com/methodology
