# K021933: Tempfix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 26, 2002 after 75 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: 1 generation back to K875022 (1988). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000957: Hoffmann II External Fixation System, Howmedica Osteonics Corp. (2000)
- K984357: Transfx External Fixation System, Immedica, Inc. (1999) Summary page 1.
- K936045: Ace Unilateral Fixator II, Ace Orthopedic Manufacturing Co. (1994) Summary page 1.
- K875022: Ace/Fisher Percutaneous Transfixing Pins, Buckman Co., Inc. (1988) Summary page 1.
- K875012: Ace/Fischer Percutaneous Half Pins, Buckman Co., Inc. (1988) Summary page 1.
- K955388: Ace-Dupont Composite Rings, Ace Medical Co. (1996) Summary page 1.

## Most influential descendants
- K052918: Reprocessed External Fixation Devices (2006), 0 descendants of its own
- K043113: Tempfix External Fixation System, MR Safe (2005), 0 descendants of its own

## Indications for use
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments. The TempFix External Fixation System is intended to be non-weight bearing.

Source page: https://510kreport.com/device/K021933
Methodology: https://510kreport.com/methodology