# K980841: Rci Fixation Screws

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 20, 1998 after 77 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 K915424 (1993). 2 ancestors in all.
95 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915424: Arthrex Cannulated Interference Screw, Arthrex, Inc. (1993) Summary page 2.
- K945687: Rounded Cannulated Inside-Out (Rci) Acl Screw, Smith and Nephew Donjoy, Inc. (1995) Summary page 2.

## 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
RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K980841
Methodology: https://510kreport.com/methodology