# K040542: Smith & Nephew GTS Sleeve and GTS Tapered Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 19, 2004 after 170 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: 4 generations back to K915424 (1993). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener, Innovasive Devices, Inc. (1999) Summary page 1.
- K032224: Biorci Screw, Smith & Nephew, Inc. (2003) Summary page 1.
- K992396: Biorci Screw, Smith & Nephew Endoscopy, Inc. (2000) Summary page 1.

## Most influential descendants
- K093943: Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM (2010), 1 descendant of its own
- K230874: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (2023), 0 descendants of its own
- K143172: ACL SMART System (2015), 0 descendants of its own

## Indications for use
The Smith & Nephew GTS Sleeve and GTS Tapered Screw are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K040542
Methodology: https://510kreport.com/methodology