# K113327: Hoffmann LRF (Limb Reconstruction Frame) System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Mar 29, 2012 after 140 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994143 (2000). 4 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 2.
- K041706: Hoffmann II Foot Ring, Howmedica Osteonics Corp. (2004) Summary page 2.
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 2.

## Most influential descendants
- 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
- K161753: Hoffman LRF System (2016), 12 descendants of its own

## Recalls of this device
- Mar 12, 2018 · Class II · Z-1526-2018: The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
- Oct 25, 2012 · Class II · Z-0695-2013: Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
- Jul 3, 2012 · Class II · Z-0266-2013: Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.

## Indications for use
The Stryker Hoffmann 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 bo~nes 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 Hoffmann 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 Lisfiranc dislocations

Source page: https://510kreport.com/device/K113327
Methodology: https://510kreport.com/methodology