# K081510: Tiger Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Aug 4, 2008 after 67 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) similar previously cleared cannulated screws: named in the summary without a submission number

## Most influential descendants
- K122959: Hammer Toe Implant (2012), 22 descendants of its own
- K140148: Pro-Toe Hammertoe Fixation System (2014), 20 descendants of its own
- K112737: Tiger Headless Cannulated Screws (2011), 12 descendants of its own
- K142585: PhaLinx Hammertoe System (2014), 9 descendants of its own
- K153338: Tiger Cannulated Screw System (2016), 7 descendants of its own

## Recalls of this device
- 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.
- 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.
- Jul 20, 2015 · Class II · Z-2421-2015: The cutting efficiency of the Countersinks was out of specification.
- Jul 20, 2015 · Class II · Z-2452-2015: The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
- Apr 14, 2009 · Not classified · Z-1438-2010: Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconc

## Indications for use
The Tiger Cannulated Screw Fixation System implants (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/K081510
Methodology: https://510kreport.com/methodology