# K080408: External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp, 9.5MM Rod

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Apr 25, 2008 after 71 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 K961916 (1996). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053472: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2006) Summary page 1.
- K011136: Apex Fixation Pins, Howmedica Osteonics Corp. (2001) Summary page 1.
- K961916: Hoffmann II Carbon Connecting Rod, Howmedica, Inc. (1996) Summary page 2.

## Most influential descendants
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (2014), 1 descendant of its own
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own

## Indications for use
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.

Source page: https://510kreport.com/device/K080408
Methodology: https://510kreport.com/methodology