# K131722: I.T.S. Extremity Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: I.T.S. GmbH
- Decided: Aug 7, 2013 after 56 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 151 ancestors in all.
24 later devices descend from it; 7 cite it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 1.
- K060613: Variax Locking Plate System, Howmedica Osteonics Corp. (2006) Summary page 1.
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 1.
- K083447: Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50, Memometal Technologies (2009) Summary page 1.
- K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories, Smith & Nephew, Inc. (2009) Summary page 1.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 1.
- K014154: Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone Screws DB1 Thread,Model F20-XX-00, Vilex, Inc. (2002) Summary page 1.
- K070039: Memometal Fixos Screws, Memometal Technologies (2007) Summary page 1.
- K091798: Merete Compression Screws, Merete Medical GmbH (2009) Summary page 1.
- K071639: Qwix Positioning Screw, Newdeal Sas (2007) Summary page 1.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 1.
- K071479: Sbi Stafix, Small Bone Innovations, Inc. (2007) Summary page 1.
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009) Summary page 1.
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K043583: Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003, Wrightmedicaltechnologyinc (2005) Summary page 1.

## Most influential descendants
- K172617: Treace Medical Concepts (TMC) Compression Screw System (2017), 11 descendants of its own
- K213036: Treace Medical Concepts (TMC) Screw Fixation System (2021), 7 descendants of its own
- K240173: Treace Medical Systems (TMC) Plating System (2024), 4 descendants of its own
- K242415: TMC Compression Implant System (2024), 3 descendants of its own
- K210935: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) (2022), 3 descendants of its own

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1605-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
- Jan 23, 2026 · Class II · Z-1606-2026: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

## Indications for use
The intended use of the 1.r.S- Exte mit Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories: The iTS. FLS- Foot Locking Plates Syste Is Indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use. The 1.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicorlical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; wail osteotomy; fusion pf the first metatarsalphalangeal joint and interphalageal joint: fixation of osteotomies for Haliux Valgus treatment (such as Scarf, Chevron, etc.); Aikin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, maileolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. And for sizes 4.3mmn or larger Is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication, Not for spinal use The IT.S. HOL - Hallux Osteotomy Locking Plate System is Indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 250. Not for spinal use. The I.TS. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Well-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.

Source page: https://510kreport.com/device/K131722
Methodology: https://510kreport.com/methodology