# K122208: External Fixator System

- Pathway: 510(k) (Traditional)
- Applicant: Christopher D. Endara
- Decided: Dec 20, 2012 after 148 days
- Product code: NDK (System, External Fixator (With Metallic Invasive Components))
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K831576 (1983). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101375: Trimed X-Fix, TriMed, Inc. (2010) Summary page 1.
- K973017: Synthes Combination Clamp and Dynamization Clip, Synthes (Usa) (1997) Summary page 1.
- K971755: Hoffmann II Compact External Fixation System, Howmedica Corp. (1997) Summary page 1.
- K030390: Synthes Large Combination Clamp and Dynamization Clip - MR Safe, Synthes (Usa) (2003) Summary page 1.
- K040258: Synthes Medium External Fixation System-MR Safe, Synthes (Usa) (2004) Summary page 1.

## Indications for use
The external fixation system is a device intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Source page: https://510kreport.com/device/K122208
Methodology: https://510kreport.com/methodology