(260 days)
Not Found
No
The device description and intended use focus on mechanical components for external fixation and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to stabilize bone segments, treat fractures, reconstruct deformities, prevent and treat contractures, and address various other musculoskeletal issues, all of which align with the definition of a therapeutic device.
No
Explanation: The device description and intended use clearly state that the Life Spine External Fixation System is a component system used to stabilize bone segments for treatment of various orthopedic conditions in the foot and ankle. It is a therapeutic device, not one used for diagnosis.
No
The device description explicitly lists physical components made of Radel, Stainless Steel, and Aluminum, such as rings, struts, threaded rods, pins, wires, and connectors. This indicates it is a hardware-based medical device, not software-only.
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 device used for stabilizing bone segments in the foot and ankle for various surgical procedures (fusion, fracture treatment, deformity correction, etc.). This is a surgical device used directly on the patient's body.
- Device Description: The device description details components like rings, struts, rods, pins, and wires made of materials like Radel, Stainless Steel, and Aluminum. These are all components of a mechanical external fixation system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant/external support system used on the body.
N/A
Intended Use / Indications for Use
The Life Spine External Fixation System is intended for Adults:
Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid
Treatment of fractures including:
Treatment of LisFranc 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 infection 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 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.
Correction of bony or soft tissue deformities Correction of segmental or nonsegmental bony or soft tissue defects Use on long bones including 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 Life Spine External Fixation System is a component system of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize bone segments for indications within the foot and ankle. The External Fixture system is fabricated of both Radel, Stainless Steel (316L) and Aluminum. The implant components are fabricated and manufactured from the following:
- Stainless Steel (316L)
All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the External Fixation System components with components from any other system or manufacturer. The External Fixation System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform, metatarsal cuboid, calcaneus, talus, cuboid, navicular, cuneiforms, metatarsals, ankle, distal tibia, long bones including tibia and fibula
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use
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 testing according to ASTM F1541 including Static and Dynamic Compressions, Dynamic Axial Compression Testing, Static Torsion Testing and Static 4-point Bending was presented to demonstrate the substantial equivalency of the External Fixation System.
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.
Wright Medical Salvation External Fixation System (K162033), Orthofix True Lock Ring Fixation System (K170650), Vilex Static Stabilization System (K151881), Stryker Hoffman External Fixation (K122284)
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
September 7, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Life Spine Inc. Randy Lewis General Manager 13951 S Quality Drive Huntley, Illinois 60142
Re: K173883
Trade/Device Name: 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: August 10, 2018 Received: August 13, 2018
Dear Randy Lewis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-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. Peter G. Allen -S 2018.09.07 13:07:38 -04'00' Mark N. Melkerson FOR 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) K173883
Device Name External Fixation System
Indications for Use (Describe) The Life Spine External Fixation System is intended for Adults:
Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid
Treatment of fractures including:
Treatment of LisFranc 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 infection 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 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.
Correction of bony or soft tissue deformities Correction of segmental or nonsegmental bony or soft tissue defects Use on long bones including tibia and fibula Use with or without IM nail in the ankle in Charcot patients
3
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K173883
510(k) Summary External Fixation System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | December 18th, 2017 |
| Trade Name: | External Fixation System |
| Regulation Name: | Screw, Fixation, Bone |
| Classification: | KTT, CFR 888.3030, Class II |
| Primary Predicate: | Wright Medical Salvation External Fixation System (K162033) |
| Secondary Predicate: | Orthofix True Lock Ring Fixation System (K170650)
Vilex Static Stabilization System (K151881)
Stryker Hoffman External Fixation (K122284) |
Device Description:
The Life Spine External Fixation System is a component system of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize bone segments for indications within the foot and ankle. The External Fixture system is fabricated of both Radel, Stainless Steel (316L) and Aluminum. The implant components are fabricated and manufactured from the following:
- Stainless Steel (316L)
All implant components are intended for single use only and should not be reused under any circumstances. Do not use any of the External Fixation System components with components from any other system or manufacturer. The External Fixation System components should never be reused under any circumstances.
5
Indications for Use of the Device:
The Life Spine External Fixation System is intended for Adults:
Fusion of the foot including: Triple arthrodesis Isolated hindfoot arthrodesis Midfoot arthrodesis Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third - e.g. Lapidus, MT), metatarsal cuboid
Treatment of fractures including:
Treatment of LisFranc 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 infection 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 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.
Correction of bony or soft tissue deformities Correction of segmental or nonsegmental bony or soft tissue defects Use on long bones including tibia and fibula Use with or without IM nail in the ankle in Charcot patients
6
Technological Characteristics:
The External Fixation System is substantially equivalent to the predicate system in terms of geometry, design, indications for use, and sizing. Both systems include similar struts, rods, and rings.
Material:
The External Fixation System is comprised of Stainless Steel, Radel and Aluminum. The implant is Stainless Steel (316L) manufactured according to ASTM F138. The implant device is comprised of non-sterile Stainless Steel and is a single use component.
Performance Data:
Mechanical testing according to ASTM F1541 including Static and Dynamic Compressions, Dynamic Axial Compression Testing, Static Torsion Testing and Static 4-point Bending was presented to demonstrate the substantial equivalency of the External Fixation System.
Conclusion:
The information presented demonstrates the substantial equivalency of the External Fixation System.