# K162033: SALVATION External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical
- Decided: Mar 6, 2017 after 227 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: 4 generations back to K941048 (1994). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043174: Stealth Fusion System, Model RR 1000, R&R Medical, Inc. (2005) Summary page 5.
- K052005: R&R External Fixation System, R&R Medical, Inc. (2005) Summary page 5.
- K153635: SALVATION (R) External Fixation System, Wrightmedicaltechnologyinc (2016) Summary page 5.

## Most influential descendants
- K180832: SALVATION External Fixation System (2018), 1 descendant of its own
- K200343: FusionFrame Ring Lock System (2020), 0 descendants of its own
- K173883: External Fixation System (2018), 0 descendants of its own

## Indications for use
The SALVATION® External Fixation System is intended for: • Fusions of the foot including: o Triple arthrodesis o Isolated hindfoot arthrodesis o Midfoot arthrodesis o Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third – e.g. Lapidus, TMT), metatarsal cuboid • Treatment of fractures including: o Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient o Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or metatarsals (including Jones fractures), ankle, and distal tibia o Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation • Reconstruction of deformities including: o Neuropathic deformities o Charcot reconstruction with or without corrective osteotomies o Diabetic Charcot Reconstruction o Prevention and treatment of contracture of joints and tendons in equinus • Treatment of infected unions, nonunions, or malunions • Offloading and or immobilization of ulcers and/or wounds of the foot or ankle • Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs and transfers both deep and or superficial around the foot and ankle including posterior tibial, tibialis anterior, flexor digitorum longus, achilles, flexor hallucis longus, peroneus brevis, peroneus longus, extensor hallucis longus, extensor digitorum longus • Tumor and neoplasm resection and reconstruction • Stabilization associated with rotation flaps, free flaps, muscle flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives • Pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction osteogenesis including bone transport • Correction of bony or soft tissue deformities • Correction of segmental or nonsegmental bony or soft tissue defects • Use on long bones including the tibia and fibula • Use with or without IM nail in the ankle in Charcot patients

Source page: https://510kreport.com/device/K162033
Methodology: https://510kreport.com/methodology