(68 days)
Not Found
No
The device description and intended use focus on mechanical components and their application in external fixation. There is no mention of AI, ML, or any software-driven analytical capabilities.
Yes
The device is used for the treatment of various medical conditions, including fusions, fractures, deformities, infections, nonunions, malunions, ulcers, and for stabilization in surgeries, which are all therapeutic purposes.
No
The device description and intended use indicate that the SALVATION External Fixation System is a surgical implant used for stabilization, fusion, and reconstruction of bones, not for diagnostic purposes.
No
The device description explicitly lists physical components such as rings, wires, bolts, bushings, rocker plates, insoles, and outsoles, indicating it is a hardware-based external fixation system.
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 bones in the foot, ankle, and lower leg for various surgical procedures (fusions, fracture treatment, deformity correction, etc.). This is a surgical device used directly on the patient's body.
- Device Description: The device description details mechanical components like rings, wires, bolts, etc., which are used to physically stabilize bones. This aligns with the description of an external fixation system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the SALVATION External Fixation System is a medical device, specifically an external fixation system, and not an In Vitro Diagnostic device.
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, 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 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 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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
The current SALVATION External Fixation System consists of rings, wires, wire fixation bolts, wire posts with bolts, half pin cubes with bolts, bushings, rocker plates with outsoles, insoles, etc. The Proximal Tibial Ring, Distal Tibial Ring and Foot Ring are designed with slots. This slot feature allows the fixation elements to slide to the desired position as opposed to the user having to handle small components (wire bolt and nut) to attach to the rings or taking the bolt out and placing it into a different hole. The system also includes tab rings with fixation holes to be used based on surgeon preference. As cleared in 510(k) K162033, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third), metatarsal cuboid, calcaneus, talus, cuboid, navicular, cuneiforms, metatarsals, ankle, distal tibia, long bones including the tibia and 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)
Mechanical Pull-out testing, Finite Element Analysis, and Engineering analysis demonstrated substantial equivalence comparing each modified component to the predicate components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
Wright Medical Technology, Inc. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K180832
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: May 10, 2018 Received: May 11, 2018
Dear Rachel Roberts:
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 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.
June 6, 2018
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K180832
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, 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 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
3
| • 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 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)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K180832 Page 1 of 3
1023 Cherry Road Memphis, TN 38117
901 867 9971
800 238 7117
wright.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: | March 29, 2018 |
| Contact Person: | Rachel Roberts
Regulatory Affairs
Specialist
Office - (901) 867-9708
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | SALVATION External Fixation System |
| 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: | K052005: SIDEKICK™ Circular Fixator
(formerly R&R External Fixator
System)
K130044: SIDEKICK™ EZ FRAME Fixator
K162033: SALVATION™ External
Fixation System |
(a)(4). Device Description
The current SALVATION External Fixation System consists of rings, wires, wire fixation bolts, wire posts with bolts, half pin cubes with bolts, bushings, rocker plates with outsoles, insoles, etc. The Proximal Tibial Ring, Distal Tibial Ring and Foot Ring are designed with slots. This slot feature allows the fixation elements to slide to the desired position as opposed to the user having to handle small components (wire bolt and nut) to attach to the rings or taking the bolt out and placing it into a different hole. The system also includes tab rings with fixation holes to be used based on surgeon preference. As cleared in 510(k) K162033, 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.
5
(a)(5). INTENDED USE
Wright's SALVATION™ External Fixation System is intended for:
- . Fusions of the foot including:
- o Triple arthrodesis
- Isolated hindfoot arthrodesis O
- Midfoot arthrodesis O
- 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:
- O Neuropathic deformities
- Charcot reconstruction with or without corrective osteotomies O
- 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
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. The fundamental scientific technology of the modified device has not change relative to the predicate devices.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Mechanical Pull-out testing, Finite Element Analysis, and 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 identical to the predicate SALVATION™ External Fixation System K162033.
(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.