# K153377: Hoffmann LRF (Limb Reconstruction Frame) System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Apr 11, 2016 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K994143 (2000). 8 ancestors in all.
13 later devices descend from it; 1 cites 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)
- K140961: Hoffmann LRF (Limb Reconstruction Frame) System, Stryker Trauma AG (2014) Summary page 4.
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 4.

## Most influential descendants
- 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
- K203568: Hoffmann LRF System (2021), 8 descendants of its own
- K212895: Paragon 28 External Ring Fixation System (2021), 5 descendants of its own

## Recalls of this device
- Feb 7, 2023 · Class II · Z-1191-2023: Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the d
- Apr 26, 2017 · Class II · Z-2160-2017: Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the

## Indications for use
The Hoffmann LRF 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, diaphyseal, 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 • Bone transport The 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 • Lisfranc dislocations

Source page: https://510kreport.com/device/K153377
Methodology: https://510kreport.com/methodology