# K043113: Tempfix External Fixation System, MR Safe

- Pathway: 510(k) (Abbreviated)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 21, 2005 after 72 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K875022 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021933: Tempfix External Fixation System, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K011034: Synthes (Usa) Medium External Fixation System, Synthes (Usa) (2001)
- K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws, Electro-Biology, Inc. (1996) Summary page 1.

## Indications for use
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities. When used without adjunctive support, the TempFix External Fixation System is intended to be non-weight bearing. The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.

Source page: https://510kreport.com/device/K043113
Methodology: https://510kreport.com/methodology