# K130334: Hoffmann LRF (Limb Reconstruction Frame System)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: May 3, 2013 after 81 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: 3 generations back to K994143 (2000). 5 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113327: Hoffmann LRF (Limb Reconstruction Frame) System, Stryker Corp. (2012) Summary page 2.
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K161753: Hoffman LRF System (2016), 12 descendants of its own
- K163656: Hoffmann LRF System (2017), 11 descendants of its own
- K182968: Hoffmann LRF System (2019), 10 descendants of its own

## Indications for use
The Stryker Hoffrnann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of: * Open and Closed Fractures * Post-traumatic joint contracture which has resulted in loss of range of motion * Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction * Pseudoarthrosis or non-union of long bones * Limb lengthening by epiphyseal or metaphyseal distraction * Correction of bony or soft tissue deformity * Correction of segmental bony or soft tissue defects * Joint arthrodesis * Management of comminuted intra-articular fractures of the distal radius The Stryker Hoffhmann LRF System is indicated in adults for: * Osteotomy * Revision procedure where other treatments or devices have been unsuccessful * Bone reconstruction procedures * Fusions and replantations of the foot * Charcot foot reconstruction * Lisfranc dislocations

Source page: https://510kreport.com/device/K130334
Methodology: https://510kreport.com/methodology