# K153338: Tiger Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Jan 14, 2016 after 56 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: 6 generations back to K962823 (1996). 28 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 36 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) Summary page 4.
- K112737: Tiger Headless Cannulated Screws, Trilliant Surgical, Ltd. (2011) Summary page 4.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 4.
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 4.
- K151021: OsteoMed Cannulated Screw System, Osteomed Corp. (2015) Summary page 4.

## Most influential descendants
- K203595: DynaFuse Fixation System (2022), 5 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
- K260995: DynaNail Helix® Fixation System (2026), 0 descendants of its own
- K260106: OsteoCoil™ GT Active Compression System (2026), 0 descendants of its own

## Recalls of this device
- Jul 19, 2018 · Class II · Z-1612-2020: 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-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.
- Dec 8, 2016 · Class II · Z-0960-2017: Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and

## Indications for use
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K153338
Methodology: https://510kreport.com/methodology