(227 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is an external fixation system intended for various medical interventions like fusions, fracture treatments, and reconstructions, all of which aim to treat or alleviate diseases, injuries, or conditions in the human body.
No
The SALVATION® External Fixation System is described as a system of aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins designed for external fixation of bone in the lower extremity. Its intended uses involve fusions, treatment of fractures, reconstruction of deformities, treatment of infected unions/nonunions/malunions, offloading/immobilization, stabilization associated with surgeries, tumor resection/reconstruction, and correction of deformities. These are all therapeutic and surgical interventions, not diagnostic procedures.
No
The device description explicitly states it includes aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for external fixation of bone in the lower extremity for various surgical procedures (fusions, fracture treatment, deformity reconstruction, etc.). This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The device is described as aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins. These are physical components used to stabilize bone, not reagents or instruments used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SALVATION® External Fixation System does not fit this description.
N/A
Intended Use / 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 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
Product codes
KTT
Device Description
The SALVATION® External Fixation System subject devices are aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins in a variety of sizes designed for external fixation of bone in the lower extremity. The implants included in this system are designed to provide versatile fixation options and accommodate variations in patient anatomy for an array of fusions, reconstructions, corrections, and stabilizations. The SALVATION® External Fixation System Line Extension is compatible with Wright's predicate SIDEKICK® predicate systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, hindfoot, midfoot, tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third), metatarsal cuboid, calcaneus, talus, cuboid, navicular, cuneiforms, metatarsals, ankle, distal tibia, long bones, tibia, fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing and analysis that demonstrated substantial equivalence include static strut testing, dynamic construct testing, and an engineering analysis comparing each subject and predicate component.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2017
Wright Medical Leslie Fitch Regulatory Affairs Manager 1023 Cherry Road Memphis. Tennessee 38117
Re: K162033
Trade/Device Name: Salvation 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: February 8, 2017 Received: February 9, 2017
Dear Leslie 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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,
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
510(k) Number (if known)
Device Name
SALVATION® External Fixation System
Indications for Use (Describe) 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 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
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X Prescription Use (Part 21 CFR 801 Subpart D)
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1023 Cherry Road Memphis. TN 38117
800 738 7117
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 SALVATION® External Fixation System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 21, 2016 |
| Contact Person: | Leslie Fitch, Ph.D.
Regulatory Affairs Manager
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 Device: | K043174: SIDEKICK® Rearfoot Fixator
(formerly STEALTH Fusion)
K052005: SIDEKICK® Circular Fixator
(formerly R&R External Fixator System)
K153635: SALVATION® External Fixation
System |
(a)(4). Device Description
The SALVATION® External Fixation System subject devices are aluminum alloy rings, stainless steel struts, and titanium nitride-coated stainless steel pins in a variety of sizes designed for external fixation of bone in the lower extremity. The implants included in this system are designed to provide versatile fixation options and accommodate variations in patient anatomy for an array of fusions, reconstructions, corrections, and stabilizations. The SALVATION® External Fixation System Line Extension is compatible with Wright's predicate SIDEKICK® predicate systems.
5
(a)(5). INTENDED USE
Wright's SALVATION External Fixation System is intended for:
- . Fusions of the foot including:
- Triple arthrodesis O
- Isolated hindfoot arthrodesis O
- O Midfoot arthrodesis
- Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-O talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, TMT), metatarsal cuboid
- Treatment of fractures including: ●
- 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, O 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
- O Charcot reconstruction with or without corrective osteotomies
- 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
- . 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 ●
6
(a)(6). Technological Characteristics Comparison
The subject devices included in the SALVATION® External Fixation System Line Extension are technologically substantially equivalent to predicate devices in material, design features, size, and mechanical strength.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and analysis that demonstrated substantial equivalence include static strut testing, dynamic construct testing, and an engineering analysis comparing each subject and predicate component.
(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 devices.