# K992396: Biorci Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Jan 12, 2000 after 177 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: 2 generations back to K915424 (1993). 5 ancestors in all.
86 later devices descend from it; 5 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980841: Rci Fixation Screws, Smith & Nephew, Inc. (1998) Summary page 1.
- K984320: Bioabsorbable Interference Screws, Smith & Nephew, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own

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

Source page: https://510kreport.com/device/K992396
Methodology: https://510kreport.com/methodology