# K151241: Synchro-Medical TIGER TRACK Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Synchro Medical
- Decided: Aug 7, 2015 after 88 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: 13 generations back to K911686 (1991). 391 ancestors in all.
No later device cites it as a predicate yet.
1 of 392 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043142: Inion Otps Biodegradable Mini Plating System, Inion, Ltd. (2005) Summary page 4.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 4.
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 4.
- K041189: Arthrex Trimit Family, Arthrex, Inc. (2004) Summary page 4.
- K071540: Sbi Titanium Threaded Pin, Small Bone Innovations, Inc. (2007) Summary page 4.
- K041456: Snap-Off Screws, Fournitures Hospitalieres Industrie (2004) Summary page 4.
- K070617: Cannulated Screw, Fournitures Hospitalieres Industrie (2007) Summary page 4.
- K895389: Depuy (TM) True Compression Screw, Depuy, Inc. (1989) Summary page 4.
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 4.
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant, In2bones Sas (2014) Summary page 4.
- K130859: Hammertoe Correction System, Arthrosurface, Inc. (2013) Summary page 4.
- K120739: Aequalis Adjustable Modular Reverse Shoulder System, Tornier, Inc. (2012) Summary page 4.
- K133036: Apollo Suture Anchor System and Titan Screws, Amendia, Inc. (2014) Summary page 4.
- K133235: Threaded Peek K-Wire, Mtp Solutions, LLC (2014) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.

## Indications for use
The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile. The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation for small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication. The TIGER TRACK® screw system is not for spinal use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated.

Source page: https://510kreport.com/device/K151241
Methodology: https://510kreport.com/methodology