# K982497: Arthrotek Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 16, 1998 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041274: Resorbable Interference Screw (2004), 26 descendants of its own
- K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 (1999), 16 descendants of its own
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (2004), 15 descendants of its own
- K052080: Matryx Interference Screw (2005), 13 descendants of its own
- K070389: Peek Knotless Anchors (2007), 9 descendants of its own

## Recalls of this device
- Jul 20, 2018 · Class II · Z-3176-2018: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
- Jul 20, 2018 · Class II · Z-3177-2018: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
- Mar 28, 2018 · Class II · Z-1739-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Mar 28, 2018 · Class II · Z-1734-2018: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
- Jun 3, 2015 · Class II · Z-1945-2015: Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the inco

## Indications for use
The Arthrotek Interference Screw is indicated for the following uses: 1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament(ACL) reconstruction. 2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis). 3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction. Implantation of the Intereference Screw is accomplished through arthroscopy and arthrotomy.

Source page: https://510kreport.com/device/K982497
Methodology: https://510kreport.com/methodology