(148 days)
Not Found
No
The document describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is indicated for treatment of the hyperpronated foot and stabilization of the subtalar joint, which falls under the definition of a therapeutic device.
No
The device is an implant designed to treat a medical condition (hyperpronation of the foot) by physically stabilizing a joint, not to diagnose a condition.
No
The device description clearly states it is a titanium implant and includes instruments for placement, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant designed to be placed inside the body to treat a physical condition (hyperpronation of the foot). It is a physical device used for structural support and stabilization, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The LIFE SPINE Subtalar implants are intended for single use only.
Product codes
HWC
Device Description
The LIFE SPINE Subtalar Implant System is a one piece titanium implant for treating hyperpronation of the foot. The system includes instruments (trial sizers, k-wires, and driver) to facilitate placement of the implant. Implants are manufactured from titanium alloy (Ti 6Al-4V ELI).
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Subtalar Implant System components with components from any other system or manufacturer. The Subtalar Implant 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, subtalar joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Engineering rationale was presented to demonstrate the substantial equivalency of the Life Spine Subtalar Implant System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Metasurg Subtalar Implant (K070441), Graham Medical HyProCure (K042030)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 and 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 a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Life Spine Incorporated Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K160169
Trade/Device Name: The Life Spine Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 24, 2016 Received: March 25, 2016
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. 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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
The Life Spine Subtalar Implant System
Indications for Use (Describe)
The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The LIFE SPINE Subtalar implants are intended for single use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [] Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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510(k) Summary
The LIFE SPINE Subtalar Implant System
| Submitted By: | Life Spine
13951 S Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
General Manager
Life Spine
13951 S Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 22nd, 2016 |
| Common Name: | Subtalar Arthroereisis Implant |
| Trade Name: | The LIFE SPINE Subtalar Implant System |
| Classification: | HWC, CFR 888.3040, Class II |
| Primary Predicate Device: | Metasurg Subtalar Implant (K070441) |
| Additional Predicates: | Graham Medical HyProCure (K042030) |
Device Description:
The LIFE SPINE Subtalar Implant System is a one piece titanium implant for treating hyperpronation of the foot. The system includes instruments (trial sizers, k-wires, and driver) to facilitate placement of the implant. Implants are manufactured from titanium alloy (Ti 6Al-4V ELI).
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Subtalar Implant System components with components from any other system or manufacturer. The Subtalar Implant System components should never be reused under any circumstances.
4
Intended Use of the Device:
The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The LIFE SPINE Subtalar implants are intended for single use only.
Technological Characteristics:
The Life Spine Subtalar Implant System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.
Material:
The Life Spine Subtalar Implant System is manufactured from implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.
Performance Data:
Engineering rationale was presented to demonstrate the substantial equivalency of the Life Spine Subtalar Implant System.
Conclusion:
The Life Spine Subtalar Implant System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.