# K163656: Hoffmann LRF System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Apr 14, 2017 after 112 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K994143 (2000). 11 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161753: Hoffman LRF System, Stryker GmbH (2016) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 4.

## Most influential descendants
- 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
- K232838: Monkey RingsTM External Fixation System (2023), 3 descendants of its own
- K241563: Extremity Medical External Fixation System (2025), 1 descendant of its own

## Recalls of this device
- Aug 28, 2018 · Class II · Z-0289-2019: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced pr
- Aug 28, 2018 · Class II · Z-0290-2019: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced pr
- Aug 28, 2018 · Class II · Z-0291-2019: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced pr
- Aug 28, 2018 · Class II · Z-0288-2019: The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced pr
- Jul 26, 2018 · Class II · Z-3240-2018: When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously acce

## Indications for use
The Stryker 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/K163656
Methodology: https://510kreport.com/methodology