# K093943: Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MM

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Mar 5, 2010 after 73 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 6 generations back to K961555 (1996). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 1.
- K040542: Smith & Nephew GTS Sleeve and GTS Tapered Screw, Smith & Nephew, Inc. (2004) Summary page 1.
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener, Innovasive Devices, Inc. (1999) Summary page 1.

## Most influential descendants
- K230874: Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (2023), 0 descendants of its own

## Indications for use
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is indicated for use in combination with BIOSURE PK Screws for Fixation of soft tissue to bone during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K093943
Methodology: https://510kreport.com/methodology