# K965029: Stableloc II External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Feb 19, 1997 after 64 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) Orthofix Dynamic Axial Fixation System: named in the summary without a submission number

## Most influential descendants
- K042066: Klsa Martin Hand Distractor (2004), 0 descendants of its own

## Recalls of this device
- Jul 9, 2008 · Not classified · Z-1154-2010: Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.

## Indications for use
The Stableloc II External IFixation System is used to address Colles’ fractures and distal radial osteotomies and is not intended for use in the spine.

Source page: https://510kreport.com/device/K965029
Methodology: https://510kreport.com/methodology