# K984320: Bioabsorbable Interference Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 28, 1999 after 56 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: 1 generation back to K945303 (1996). 1 ancestor in all.
103 later devices descend from it; 3 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945303: Arthrex Bioabsorbable Interference Screw, Arthrex, Inc. (1996) Summary page 1.

## Most influential descendants
- K992396: Biorci Screw (2000), 86 descendants of its own
- K051310: PLC Screw (2005), 71 descendants of its own
- K071176: Modification to: Arthrex Interference Screw (2007), 47 descendants of its own
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own
- K171141: Arthrex SwiveLock Anchors (2017), 29 descendants of its own

## Indications for use
The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. The screw is indicated for single use only.

Source page: https://510kreport.com/device/K984320
Methodology: https://510kreport.com/methodology