# K253202: Hoffmann LRF System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Dec 19, 2025 after 84 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: 14 generations back to K962616 (1996). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233741: Hoffmann LRF System, Stryker GmbH (2023) Summary page 5.
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 5.
- K071394: Modification to:Sbi Ringfix, Small Bone Innovations, Inc. (2007) Summary page 5.
- K210953: SMART Taylor Spatial Frame, Smith & Nephew, Inc. (2021) Summary page 5.
- K211313: MAXFRAME Multi-Axial Correction System (aka MAXFRAME), Synthes (USA) Products, LLC (2021) Summary page 5.
- K231922: DEPUY SYNTHES MAXFRAME AUTOSTRUT System, DePuy Synthes (2023) Summary page 5.
- K201253: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation, Smith & Nephew (2020). Our reading of the summary gave K201353, FDA’s number for CenterMed Patient Matched Assisted Surgical Planning (ASP)… (Centermed, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “S&N Ilizarov Frame”.

## Indications for use
The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients 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/K253202
Methodology: https://510kreport.com/methodology