# K112218: Ace-Fischer (R), Tempfix (R), Hoffman Classic (TM) External Fixators

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 15, 2011 after 135 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181630: Revolution External Plating System (2019), 1 descendant of its own
- K233025: Revolution External Plating System (2024), 0 descendants of its own

## Indications for use
Indicated for Open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.

Source page: https://510kreport.com/device/K112218
Methodology: https://510kreport.com/methodology