# K152045: SALVATION® External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 21, 2015 after 29 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: 3 generations back to K941048 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150004: SALVATION External Fixation System, Wrightmedicaltechnologyinc (2015) Summary page 5.
- K130044: Sidekick EZ Frame External Fixation System, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K100137: Sidekick Circular Fixator System: Struts and Hinges, Wrightmedicaltechnologyinc (2010) Summary page 5.

## Indications for use
SALVATION(R) 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-talo-calcaneus, naviculocuneiform, metatarsal cuneiform (1st, second, third – e.g. Lapidus, TMT), metatarsal cuboid • Treatment of fractures including: o Treatment of Lis Franc 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/K152045
Methodology: https://510kreport.com/methodology