# K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Biomaterials, Inc.
- Decided: May 7, 2004 after 233 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: 6 generations back to K933738 (1994). 29 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030, Bionx Implants, Ltd. (1999) Summary page 1.
- K012572: Soft Tissue Screw and Washer, Biomet, Inc. (2001)
- 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.
- K993630: Biolok Screw, Encore Orthopedics, Inc. (2000) Summary page 1.
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.

## Most influential descendants
- K052080: Matryx Interference Screw (2005), 13 descendants of its own
- K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 (2010), 5 descendants of its own
- K063588: Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 (2007), 3 descendants of its own
- K170501: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (2017), 2 descendants of its own
- K102410: Matryx Interference Screw (5.0-6.5MM) (2010), 2 descendants of its own

## Indications for use
The Osteo ACL Screw TM is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The Osteo ACL ScrewTM is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation 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/K032894
Methodology: https://510kreport.com/methodology