(271 days)
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No
The summary describes a physical implant and its intended use, with no mention of software, algorithms, or AI/ML technologies. Performance studies are based on traditional engineering analysis and bench testing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for use in the treatment of patients with degenerative and post-traumatic arthritis," indicating its therapeutic purpose.
No
The provided text describes the Life Spine Metatarsal Hemi Implant as a device used to treat patients with degenerative and post-traumatic arthritis. It is an implant designed to resurface the metatarsal head. It is intended for treatment, not for diagnosing conditions.
No
The device description clearly states it is an "implant" with a "tapered stem and a rounded head," indicating a physical hardware 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. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Life Spine Metatarsal Hemi Implant is an implant that is surgically placed inside the body to treat a specific anatomical issue (arthritis in the metatarsophalangeal joint).
- Intended Use: The intended use describes a surgical procedure and the treatment of a condition within the body, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone with the following clinical conditions: hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) ioint. The device is a single use implant intended to be used with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The Life Spine Metatarsal Hemi Implant is an implant that has a tapered stem and a rounded head. The tapered stem allows for the implant to be fixated into the 1st metatarsal. The rounded head resurfaces the metatarsal head in the metatarso-phalangeal joint.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the The Life Spine Metatarsal Hemi Implant components with components from any other system or manufacturer. The Hemi Metatarsal Head Resurfacing System components should never be reused under any circumstances.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
metatarsophalangeal joint, metatarsal joint, metatarsal head
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)
Finite Element Analysis, bench testing (static and dynamic) as well as engineering rationale was presented to demonstrate the substantial equivalency of The Life Spine Metatarsal Hemi Implant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Solana Surgical Metatarsal Decompression Implant (K090127), Osteolink Metatarsal Resurfacing Implant (K081876)
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
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
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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 a stylized image of a human figure, represented by three overlapping profiles, with flowing lines extending downwards, resembling a wave or a stylized body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2017
Life Spine Inc. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K161279
Trade/Device Name: Life Spine Metatarsal Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: January 5, 2017 Received: January 6, 2017
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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 yours,
Mark N. Melkerson -S
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) K161279
Device Name
The Life Spine Metatarsal Hemi Implant
Indications for Use (Describe)
The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone with the following clinical conditions: hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) ioint. The device is a single use implant intended to be used with bone cement.
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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510(k) Summary
The Life Spine Metatarsal Hemi Implant
| 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: | January 24th, 2017 |
| Trade Name: | The Life Spine Metatarsal Hemi Implant |
| Common Name: | MTP Hemi-Toe Prosthesis |
| Classification: | KWD, CFR 888.3730, Class II |
| Predicate Device: | Solana Surgical Metatarsal Decompression Implant
(K090127) |
| Additional Predicate: | Osteolink Metatarsal Resurfacing Implant (K081876) |
Device Description:
The Life Spine Metatarsal Hemi Implant is an implant that has a tapered stem and a rounded head. The tapered stem allows for the implant to be fixated into the 1 * metatarsal. The rounded head resurfaces the metatarsal head in the metatarso-phalangeal joint.
-
- Cobalt Chrome Molybdenum Alloy (Co-28Cr-6Mo)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the The Life Spine Metatarsal Hemi Implant components with components from any other system or manufacturer. The Hemi Metatarsal Head Resurfacing System components should never be reused under any circumstances.
- Cobalt Chrome Molybdenum Alloy (Co-28Cr-6Mo)
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Indications for Use:
The Life Spine Metatarsal Hemi Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Technological Characteristics:
The Life Spine Metatarsal Hemi Implant is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.
Material:
The Life Spine Metatarsal Hemi Implant is manufactured from Cobalt Chrome Molybdenum Alloy (Co-28Cr-6Mo).
Performance Data:
Finite Element Analysis, bench testing (static and dynamic) as well as engineering rationale was presented to demonstrate the substantial equivalency of The Life Spine Metatarsal Hemi Implant.
Conclusion:
The Life Spine Metatarsal Hemi Implant was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.