(82 days)
The Metasurg 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 Metasurg subtalar implants are intended for single use only.
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 6 sizes ranging from 7mm - 12mm in diameter. The implant is used in the treatment of excessive motion of the talus relative to the calcaneus.
This is a 510(k) summary for the Metasurg Subtalar Implant, a metallic bone fixation fastener. The document establishes substantial equivalence to other legally marketed devices and outlines the intended use and device description.
It's important to note that this document states substantial equivalence to legally marketed devices, but does not provide specific acceptance criteria or an analytical study proving the device meets those criteria. The provided text is a regulatory clearance document, not a performance study report.
Therefore, many of the requested details about acceptance criteria, device performance, and study methodology cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not detail specific acceptance criteria for performance (e.g., mechanical strength, wear resistance, biocompatibility thresholds) nor does it report the Metasurg Subtalar Implant's direct performance against such criteria in a test setting. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which implies the new device is as safe and effective as the predicate, but doesn't necessarily require reporting new performance data against specific, quantifiable acceptance criteria in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This document does not describe any specific test set or clinical study conducted for the Metasurg Subtalar Implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no test set or ground truth described in this regulatory clearance document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an implant, not an AI-assisted diagnostic tool, and this document does not describe any MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No specific ground truth is mentioned as this is a regulatory submission based on substantial equivalence, not a clinical trial report.
8. The sample size for the training set
- Not applicable. This involves an implant, not a machine learning model with a training set.
9. How the ground truth for the training set was established
- Not applicable. This involves an implant, not a machine learning model, and therefore no training set or its ground truth establishment is discussed.
Summary of Device Information from the Document:
- Device Trade Name: Metasurg Subtalar Implant
- Classification Name: Smooth & threaded metallic bone fixation fasteners (21 CFR 888.3040, Product Code HWC, Class II)
- Common Name: Subtalar Arthrorisis Implant
- Device Description: A one-piece device made of titanium, implanted into the sinus tarsi of the foot. Offered in 6 sizes (7mm - 12mm diameter).
- Intended Usage/Indications for Use: Treatment of the hyperpronated foot and stabilization of the subtalar joint. Designed to block forward, downward, and medial displacement of the talus, allowing normal subtalar joint motion but blocking excessive pronation and its sequela. Intended for single use only.
- Material: Titanium Alloy (Ti-6AL-4V ELI)
- Substantial Equivalence: Documentation was provided to demonstrate substantial equivalence to other legally marketed devices. This is the primary "proof" used for 510(k) clearance, implying the device is as safe and effective as its predicate.
This 510(k) summary focuses on demonstrating that the Metasurg Subtalar Implant is substantially equivalent to devices already on the market. It does not provide detailed performance study data against specific acceptance criteria for the new device itself. Such data would typically be found in engineering testing reports (e.g., for mechanical properties) or clinical study reports, which are not included in this summary.
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MAY 8 -2007
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Kop44//
510(k) Summary
| Date Prepared: | February 14, 2007 |
|---|---|
| Sponsor: | Metasurg16350 Park Ten Place, Suite 101Houston, TX 77084 |
| Company Contact: | Larry WeatherfordPhone: (281) 398-5656Fax: (281) 398-5660 |
| Device Trade Name: | Metasurg Subtalar Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21 CFR888.3040, Product Code HWC, Class II) |
| Common Name: | Subtalar Arthrorisis Implant |
| Substantial Equivalence: | Documentation is provided which demonstrates the MetasurgSubtalar Implant to be substantially equivalent to other legallymarketed devices. |
| Device Description: | The Metasurg Subtalar Implant is a one-piece device made oftitanium intended to be implanted into the sinus tarsi of the foot.The implant is offered in 6 sizes ranging from 7mm - 12mm indiameter. The implant is used in the treatment of excessivemotion of the talus relative to the calcaneus. |
| Intended Usage: | The Metasurg Subtalar Implant is indicated for use in thetreatment of the hyperpronated foot and stabilization of thesubtalar joint. It is designed to block forward, downward andmedial displacement of the talus, thus allowing normal subtalarjoint motion but blocking excessive pronation and the resultingsequela.The Metasurg subtalar implants are intended for single use only. |
| Material: | Titanium Alloy (Ti-6AL-4V ELI) |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
2007 MAY 8
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Metasurg % Mr. Larry Weatherford Vice President 16350 Park Ten Place, Suite 101 Houston, Texas 77084
Re: K070441
Trade/Device Name: Metasurg Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 14, 2007 Received: February 16, 2007
Dear Mr. Weatherford:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Larry Weatherford
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely, yours,
Barbara Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: Pending
Device Name: Metasurg Subtalar Implant
Indications For Use:
The Metasurg 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 Metasurg subtalar implants are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Darlaue Buem
and Neurolog
510(k) Number K070441
§ 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.