(29 days)
The SALVATION(R) External Fixation System is intended for:
· Fusions of the foot including:
Triple arthrodesis O
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
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 3 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; and 200 MM FRAME with 200 mm proximal tibial ring, 180 mm distal tibial and 180 mm foot rings. As cleared in 510(k) K150004, the SALVATION® External Fixation System is designed so that the SIDEKICK® Circular and SIDEKICK® EZ FRAME™ components are compatible and can be used with the SALVATION® External Fixation system. The SALVATION™ External fixation system is compatible with the SIDEKICK® EZ FRAMETM External fixation System (K130044) and the SIDEKICK® CIRCULAR Fixator System (K100137).
This document is a 510(k) summary for the SALVATION® External Fixation System. It establishes substantial equivalence to predicate devices and does not describe a study proving the device meets acceptance criteria in the way typically seen for AI/ML devices or diagnostic tools.
Therefore, many of the requested fields cannot be directly answered from the provided text. This document focuses on demonstrating that the device is substantially equivalent to existing, legally marketed devices, rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis.
However, I can extract the relevant information where available and note where information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
This type of structured table for specific, quantifiable performance metrics is not provided in this 510(k) summary because it's for a physical medical device (an external fixation system) seeking clearance based on substantial equivalence, not a diagnostic or AI/ML device requiring performance metrics like sensitivity, specificity, or AUC against acceptance criteria.
The document states:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices in material, design features, mechanical strength, and indications for use.
- Reported Device Performance: "The SALVATION® External Fixation System is technologically substantially equivalent to predicate devices in material, design features, and mechanical strength. The fundamental scientific technology of the modified device has not changed relative to the predicate devices." (Page 6) and "From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device." (Page 6)
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a physical external fixation system cleared based on mechanical and material equivalence testing and a comparison to existing predicate devices, not a test set of data for an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of AI/ML or diagnostic performance studies, is not established for an external fixation system in a 510(k) process based on substantial equivalence.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of data requiring an adjudication method as understood in AI/ML performance studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This device is not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML or diagnostic studies. For this device, the "ground truth" for its safety and effectiveness is established by comparing its design, materials, and mechanical properties to legally marketed predicate devices which have established their safety and effectiveness through historical use and regulatory review. The non-clinical evidence provided involves engineering analysis.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Wright Medical Technology, Incorporated Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117
Re: K152045
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: July 21, 2015 Received: July 23, 2015
Dear Ms. Redden:
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
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Page 2 - Ms. Jeanine Redden
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
SALVATION(R) External Fixation System
Indications for Use (Describe)
SALVATION(R) External Fixation System is intended for:
· Fusions of the foot including:
Triple arthrodesis O
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)
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
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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 RoadMemphis, TN 38117 |
|---|---|
| Date: | July 21, 2015 |
| Contact Person: | Jeanine ReddenDirector, Regulatory AffairsOffice : (901) 867-4522Fax: (901) 867-4190 |
| (a)(2). Proprietary Name: | SALVATION™ External FixationSystem |
| 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® ExternalFixation SystemK130044: SIDEKICK® EZ FRAMETMExternal Fixation SystemK100137: SIDEKICK® CircularFixation 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 plates, outsoles, insoles, etc. The Proximal and Distal Tibial Rings and Foot Ring are designed with slots.
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The SALVATION® External Fixation System features 3 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; and 200 MM FRAME with 200 mm proximal tibial ring, 180 mm distal tibial and 180 mm foot rings. As cleared in 510(k) K150004, the SALVATION® External Fixation System is designed so that the SIDEKICK® Circular and SIDEKICK® EZ FRAME™ components are compatible and can be used with the SALVATION® External Fixation system. The SALVATION™ External fixation system is compatible with the SIDEKICK® EZ FRAMETM External fixation System (K130044) and the SIDEKICK® CIRCULAR Fixator System (K100137).
(a)(5). INTENDED USE
The SALVATION® External Fixation System is intended for:
- Fusions of the foot including: .
- Triple arthrodesis 0 \
- Isolated hindfoot arthrodesis O
- Midfoot arthrodesis O
- Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, o pantalar, tibio-talo-calcaneus, naviculocuneiform, metatarsal cuneiform (18) second, third - e.g. Lapidus, TMT), metatarsal cuboid
- Treatment of fractures including: o
- 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 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 transfers both deep and or superficial around the foot and ankle including
E2-2
{6}------------------------------------------------
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
- o Stabilization associated with rotation flaps, free flaps, muscle flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives
- o 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 to predicate devices in material, design features, and mechanical strength. The 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.
§ 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.