# K083789: Ace Fischer External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 23, 2009 after 94 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 K801594 (1980). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801594: Ace Fischer External Fixation Device, Ace Orthopedic Manufacturing Co. (1980) Summary page 1.
- K860018: Fischer Wire/Pin Clamp, Buckman Co., Inc. (1986). Our reading of the summary gave K860014, FDA’s number for Systems Plus (United Surgical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Fischer Wire/Pin Clamp”.
- 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
- K190486: Pitkar External Fixation System (2019), 2 descendants of its own
- K202833: Sequel External Fixation Device (2021), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own
- K111993: Framewalker (2011), 0 descendants of its own
- K093753: Mdpo Frame System (2010), 0 descendants of its own

## Indications for use
The updated ACE-Fischer® External Fixation System is 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/K083789
Methodology: https://510kreport.com/methodology