# K041706: Hoffmann II Foot Ring

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 8, 2004 after 77 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.
24 later devices descend from it; 2 cite it directly.
0 of 25 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
- K113327: Hoffmann LRF (Limb Reconstruction Frame) System (2012), 17 descendants of its own
- K130907: Hoffmann LRF (Limb Reconstruction Frame) System (2013), 15 descendants of its own
- K130334: Hoffmann LRF (Limb Reconstruction Frame System) (2013), 15 descendants of its own
- K140961: Hoffmann LRF (Limb Reconstruction Frame) System (2014), 14 descendants of its own
- K153377: Hoffmann LRF (Limb Reconstruction Frame) System (2016), 13 descendants of its own

## Indications for use
The Hoffmann ® II Hybrid Frame System is intended for use to provide stabilization of open and/or unstable fractures 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 * Bone reconstruction procedures * Fusions and replantations of the foot * Charcot foot reconstruction and Lisfranc dislocations

Source page: https://510kreport.com/device/K041706
Methodology: https://510kreport.com/methodology