Search Results

SALVATION® External Fixation System is intended for:
· Fusions of the foot including:
Triple arthrodesis
Isolated hindfoot arthrodesis
Midfoot arthrodesis
Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talo-calcaneus, naviculocuneiform, metatarsal cuneiform (1st, second, third - e.g. Lapidus, TMT), metatarsal cuboid
• Treatment of fractures including:
Treatment of Lis Franc fracture/dislocations in diabetic and Charcot neuropathy patient
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
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:

• Neuropathic deformities
• Charcot reconstruction with or without corrective osteotomies
• Diabetic Charcot Reconstruction
• 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 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, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives
  · Pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal 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

The SALVATION® External Fixation System consists of rings, wires, wire fixation bolts, wire posts with bolt, half pins, half pin cubes with bolts, bushings, rocker plates, outsoles, insoles, etc. The Proximal and Distal Tibial Rings and Foot Ring are designed with slots.
The SALVATION® External Fixation System features 4 preassembled frame options: 160 MM FRAME with 160 mm proximal tibial ring, 140 mm distal tibial ring, and 140 mm foot ring; 180MM FRAME with 180 mm proximal tibial ring, 160 mm distal tibial and 160 foot ring; 200 MM FRAME with 200 mm proximal tibial ring, 180 mm distal tibial and 180 mm foot rings; and 220 MM FRAME (subject device) with 220 mm proximal tibial ring, 200 mm distal tibial and 200 mm foot ring. As cleared in 510(k) K150004, the SALVATION® External Fixation System is designed so that the SIDEKICK® Circular and SIDEKICK® EZ FRAME™M components are compatible and can be used with the SALVATION® External Fixation system.

The provided text is a 510(k) Pre-market Notification for the SALVATION® External Fixation System. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, or study results (clinical or non-clinical in terms of specific performance data).

The section "(b)(1). Substantial Equivalence - Non-Clinical Evidence" states: "Engineering analysis demonstrated substantial equivalence comparing each modified component to the predicate components." This indicates that some form of engineering analysis was performed to verify equivalence, but it does not provide any specific quantitative performance data, acceptance criteria, or a description of the study itself.

The section "(b)(2). Substantial Equivalence - Clinical Evidence" explicitly states "N/A", meaning no clinical evidence was submitted with this particular 510(k) application. This is common for devices seeking 510(k) clearance that demonstrate substantial equivalence through non-clinical means.

Therefore, I cannot provide the requested information based on the text provided. The document focuses on regulatory approval based on substantial equivalence rather than presenting detailed performance study data.

Ask a specific question about this device