# K052037: Modification to Hoffmann II Micro External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 5, 2005 after 8 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 no predicate by number.

## Most influential descendants
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K122210: Newfix External Fixation System (2013), 0 descendants of its own
- K102843: Mac Male Adapter (2011), 0 descendants of its own

## Indications for use
The Hoffmann ® II Micro Tm External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to: * Bone fracture fixation * Osteotomy * Arthrodesis * Correction of deformity * Revision procedure where other treatments or devices have been unsuccessful * Non-unions and delayed unions * Compression/distraction and lengthening

Source page: https://510kreport.com/device/K052037
Methodology: https://510kreport.com/methodology