# K041601: Surfix Knee Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Surfix Technologies
- Decided: Aug 27, 2004 after 74 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 1 generation back to K014155 (2002). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 2.
- K014155: Opening/Closing Wedge Ostetomy Plates, Arthrex, Inc. (2002)

## Most influential descendants
- K141548: High Tibial Osteotomy System (2015), 3 descendants of its own
- K173746: Activmotion Range (2018), 1 descendant of its own
- K241539: Activmotion S (2024), 0 descendants of its own
- K212545: FlexitSystem Knee osteotomy system (2022), 0 descendants of its own
- K213214: Xpert Wrist (2021), 0 descendants of its own

## Indications for use
The SURFIX® Knee Osteotomy System is indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in the cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Examples Include: * Fixation of opening wedge high tibial osteotomy, * Fixation of fracture of the medial tibial plateau, * Osteoarthritis of the medial tibiofemoral compartment with genu varum, * Fixation of closing wedge high tibial osteotomy, * Fixation of fracture of the lateral tibial plateau, * Distal femoral varus osteotomy, * Lateral gonarthrosis on genu valgum.

Source page: https://510kreport.com/device/K041601
Methodology: https://510kreport.com/methodology