# K112737: Tiger Headless Cannulated Screws

- Pathway: 510(k) (Special)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Oct 20, 2011 after 30 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021556 (2002). 3 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081510: Tiger Cannulated Screw System, Trilliant Surgical, Ltd. (2008)
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 1.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K153338: Tiger Cannulated Screw System (2016), 7 descendants of its own
- K203595: DynaFuse Fixation System (2022), 5 descendants of its own
- K161259: KLS Martin Cannulated Headless Screws (2016), 2 descendants of its own
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (2026), 1 descendant of its own
- K233567: OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (2024), 1 descendant of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1606-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
- Jul 19, 2018 · Class II · Z-1605-2020: Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
- Sep 2, 2016 · Class II · Z-0609-2017: Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indi
- Jul 20, 2015 · Class II · Z-2464-2015: Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.

## Indications for use
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Source page: https://510kreport.com/device/K112737
Methodology: https://510kreport.com/methodology