# K071628: Stryker External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Cmf
- Decided: Aug 10, 2007 after 57 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K961916 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053038: Hoffmann II Compact Mri External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K961916: Hoffmann II Carbon Connecting Rod, Howmedica, Inc. (1996) Summary page 1.
- K971755: Hoffmann II Compact External Fixation System, Howmedica Corp. (1997) Summary page 1.
- K973321: Hoffmann II Compact Periarticular Clamp, Howmedica, Inc. (1997) Summary page 1.
- K040258: Synthes Medium External Fixation System-MR Safe, Synthes (Usa) (2004) Summary page 1.
- K062299: Synthes Sterile Mandible External Fixation Kit, Synthes (Usa) (2006) Summary page 1.

## Most influential descendants
- K072764: KLS Martin Xternal Fixator (2007), 0 descendants of its own

## Indications for use
The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Source page: https://510kreport.com/device/K071628
Methodology: https://510kreport.com/methodology