# K122455: Synthes Small External Fixation System, Synthes Large External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Apr 11, 2013 after 241 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 1 generation back to K914558 (1992). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031724: Synthes Small Cobination Clamp-MR Safe, Synthes (Usa) (2003) Summary page 1.
- K033158: Synthes Reprocessed External Fixation Devices, Synthes (Usa) (2003) Summary page 1.
- K961350: Synthes Mini External Fixator, Synthes (Usa) (1996) Summary page 1.
- K050631: Synthes (Usa) Small Adjustable Clamp-MR Safe Line Extension, Synthes (Usa) (2005) Summary page 1.
- K090658: Synthes External Fixation Devices, MR Conditional, Synthes (Usa) (2010) Summary page 1.
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 1.
- K952296: Synthes (Usa) [Synthes[ Self-Drilling Schanz Screw, Synthes (Usa) (1995) Summary page 1.
- K040701: Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws, Synthes (Usa) (2004) Summary page 1.
- K030390: Synthes Large Combination Clamp and Dynamization Clip - MR Safe, Synthes (Usa) (2003) Summary page 1.
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe, Synthes (Usa) (2003) Summary page 1.
- K962913: Synthes Sterile Drill Bits, Synthes (Usa) (1996) Summary page 1.
- K950384: Synthes (Usa) Synthes Hybrid External Fixator, Synthes (Usa) (1995) Summary page 1.
- K043039: Synthes (Usa) External Fixation Component Line Extension - MR Safe, Synthes (Usa) (2005) Summary page 1.
- K914558: Traumafix (TM) External Fixator, Synthes (Usa) (1992) Summary page 1.

## Most influential descendants
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (2014), 1 descendant of its own
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own
- K171911: Medline ReNewal Reprocessed Synthes External Fixation Systems (2017), 0 descendants of its own

## Recalls of this device
- Jul 29, 2015 · Class II · Z-2451-2015: Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System p
- Apr 10, 2014 · Class II · Z-1833-2014: Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

## Indications for use
The Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for: * Preliminary fixation before ORIF * Unstable fractures of the distal radius (both intra- and extra-articular) * Open and/or comminuted bilateral fractures * Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement * Fracture dislocations * Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations) * Pediatric open fractures with bone loss and osteotomies The Synthes Large External Fixation Systems is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: * Stabilization of soft tissues and fractures * Poyltrauma/multiple orthopedic trauma * Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures * Arthrodeses and osteotomes with soft tissue problems; failures of total joints * Neutralization of fractures stabilized with limited internal fixation * Non-unions/septic non-unions * Intra-operative reductions/stabilization tool to assist with indirect reduction * Unilateral rectilinear bone segment transport or leg lengthening

Source page: https://510kreport.com/device/K122455
Methodology: https://510kreport.com/methodology