# K032224: Biorci Screw

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 8, 2003 after 18 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: 3 generations back to K915424 (1993). 6 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992396: Biorci Screw, Smith & Nephew Endoscopy, Inc. (2000) Summary page 1.

## Most influential descendants
- K083619: Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 (2009), 7 descendants of its own
- K091093: Parcus Ppek CF Interference Screw (2009), 4 descendants of its own
- K040542: Smith & Nephew GTS Sleeve and GTS Tapered Screw (2004), 3 descendants of its own
- K193497: Fixone Biocomposite Interference Screw (2021), 1 descendant of its own
- K170877: Parcus SLiK Fix Screw (2017), 1 descendant of its own

## Indications for use
The BioRCI@Screw is used for fixation of bone-tendon-bone or soft tissue grafts during AnteriorRosterior Cruciate Ligament (ACLRCL) reconstruction procedures.

Source page: https://510kreport.com/device/K032224
Methodology: https://510kreport.com/methodology