SALVATION(R) External Fixation System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Wright Medical Technology, Incorporated Ms. Leslie Fitch Manager, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117 January 13, 2016 Re: K153635 Trade/Device Name: SALVATION(R) External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: December 18, 2015 Received: December 18, 2015 Dear Ms. Fitch: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K153635 #### Device Name SALVATION® External Fixation System Indications for Use (Describe) SALVATION® External Fixation System is intended for: · Fusions of the foot including: Triple arthrodesis 0 Isolated hindfoot arthrodesis 0 0 Midfoot arthrodesis Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talo-calcaneus, O 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 O 0 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 O or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation · Reconstruction of deformities including: - Neuropathic deformities 0 - Charcot reconstruction with or without corrective osteotomies 0 - Diabetic Charcot Reconstruction 0 - Prevention and treatment of contracture of joints and tendons in equinus 0 - · 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 Type of Use (Select one or both, as applicable) ال Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) {3}------------------------------------------------ #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ K153635 Page 1 of 3 Headquarters Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 901 867 9971 vmt.com #### 510(K) SUMMARY In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SALVATION® External Fixation System. | (a)(1). Submitted By: | Wright Medical Technology, Inc. | |------------------------------------|----------------------------------------------------------| | | 1023 Cherry Road | | | Memphis, TN 38117 | | Date: | December 18, 2015 | | Contact Person: | Leslie Fitch | | | Manager, Regulatory Affairs | | | Office: (901) 867-4120 | | | Fax: (901) 867-4190 | | (a)(2). Proprietary Name: | SALVATION ^® External Fixation System | | Common Name: | External Fixation Device | | Classification Name and Reference: | 21 CFR 888.3030 – Class II | | Device Product Code, Device Panel: | KTT, Orthopedic | | (a)(3). Predicate Devices: | K150004: SALVATION ^® External Fixation System | | | K130044: SIDEKICK ^® EZ FRAME Fixator System | | | K100137: SIDEKICK ^® Circular Fixation System | | | K052005: R&R External Fixation System | # (a)(4). Device Description 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 {5}------------------------------------------------ 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. # (a)(5). INTENDED USE The SALVATION® External Fixation System is intended for: - Fusions of the foot including: ● - Triple arthrodesis O - Isolated hindfoot arthrodesis 0 - Midfoot arthrodesis O - Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, 0 pantalar, tibio-talo-calcaneus, naviculocuneiform, metatarsal cuneiform (1), second, third - e.g. Lapidus, TMT), metatarsal cuboid - Treatment of fractures including: 0 - Treatment of Lis Franc fracture/dislocations in diabetic and Charcot neuropathy O patient - Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, O 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, O 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 O - Charcot reconstruction with or without corrective osteotomies O - Diabetic Charcot Reconstruction O - Prevention and treatment of contracture of joints and tendons in equinus O - Treatment of infected unions, nonunions, or malunions - Offloading and or immobilization of ulcers and or wounds of the foot or ankle {6}------------------------------------------------ - 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 ### (a)(6). Technological Characteristics Comparison The SALVATION® External Fixation System is technologically substantially equivalent The to predicate devices in material, design features, and mechanical strength. fundamental scientific technology of the modified device has not changed relative to the predicate devices. #### (b)(1). Substantial Equivalence - Non-Clinical Evidence Engineering analysis demonstrated substantial equivalence comparing each modified component to the predicate components. The indications for use of the subject, SALVATION® EXTERNAL FIXATION SYSTEM are the same as the indications cleared for the predicate SALVATION® EXTERNAL FIXATION K150004. # (b)(2). Substantial Equivalence - Clinical Evidence N/A ## (b)(3). Substantial Equivalence - Conclusions The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.