(39 days)
The Instratek Sub-Talar Lok arthroereisis implant restricts excessive subtalar pronation in all three planes, providing for a more normal subtalar joint motion in patients. The Sub-Talar Lok is intended for the following pathological conditions resulting from disease, injury, or other trauma.
- Hypermobile pes valgus
- Posterior tibial tendon dysfunction
- Severe pronation
- Subtalar instability
- Hypermobile flexible congenital flat foot
The Instratek Sub-Talar Lok Implant is designed to stabilize the subtalar joint of the hyperpronated foot. The implant is conical shaped with external threads of uniform depth and pitch. The device is cannulated for use with a guide wire. The product will be provided with a procedure kit containing: Five (5) dilators sized 7 through 11 mm Ten Sub-Talar Lok implants, two each of five sizes Regular driver, 4.3mm hex head Rescue driver, threaded
This submission is for a medical device (Sub-Talar Lok Implant), not an AI/ML device. Therefore, the requested information regarding AI/ML device performance, acceptance criteria, study design, expert involvement, and training/test set details is not applicable.
The document describes the device's technical characteristics and intended use within the context of a 510(k) summary for substantial equivalence to legally marketed predicate devices. The approval is based on a comparison of design, materials, intended use, and technological characteristics to existing devices, implying that the device meets acceptance criteria through this demonstration of substantial equivalence rather than a specific performance study with quantitative metrics and ground truth as would be required for an AI/ML product.
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SECTION 5. 510(K) SUMMARY
| SubmissionCorrespondent: | Instratek, Inc.210 Spring Hill DriveSuite 130Spring, TX 77386USAPhone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyVice PresidentMAR 14 2008 |
|---|---|
| Date summary prepared: | February 1, 2008 |
| Device trade name: | Sub-Talar Lok Implant |
| Device common name: | Subtalar Implant |
| Device classification name: | Screw, Fixation, Bone.HWC at 21 CFR Part 880.3040 |
| Legally marketed device towhich the device issubstantially equivalent: | K032902, Futura Conical Subtalar Implant, Nexa OrthopedicsK031155, Extremity Talar-Fit Implant, Osteomed. |
| Description of the device: | The Instratek Sub-Talar Lok Implant is designed to stabilize thesubtalar joint of the hyperpronated foot. The implant is conicalshaped with external threads of uniform depth and pitch. The deviceis cannulated for use with a guide wire. The product will be providedwith a procedure kit containing:Five (5) dilators sized 7 through 11 mmTen Sub-Talar Lok implants, two each of five sizesRegular driver, 4.3mm hex headRescue driver, threaded |
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| Intended use of the device: | The Instratek Sub-Talar Lok arthroereisis implant restricts excessivesubtalar pronation in all three planes, providing for a more normalsubtalar joint motion in patients. The Sub-Talar Lok is intended forthe following pathological conditions resulting from disease, injury, orother trauma. |
|---|---|
| • Hypermobile pes valgus | |
| • Posterior tibial tendon dysfunction | |
| • Severe pronation | |
| • Subtalar instability | |
| • Hypermobile flexible congenital flat foot | |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate devices. |
| Conclusions: | The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2008
Instratek, Inc. % Mr. Jeff Seavey 210 Spring Hill Drive Suite 130 The Woodlands, TX 77386
Re: K080280 Trade/Device Name: Sub-Talar Lok Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 1, 2008 Received: February 7, 2008
Dear Mr. Seavey:
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. Isting 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. Jeff Seavey
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark W. Mulhausen
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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SECTION 4. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K080280 |
|---|---|
| Device Name: | Sub-Talar Lok Implant |
| Indications for Use: | The Instratek Sub-Talar Lok arthroereisis implantrestricts excessive subtalar pronation in all threeplanes, providing for a more normal subtalar jointmotion in patients. The Sub-Talar Lok is intended forthe following pathological conditions resulting from |
-
Hypermobile pes valgus .
disease, injury, or other trauma. -
. Posterior tibial tendon dysfunction
-
. Severe pronation
-
t Subtalar instability
-
Hypermobile flexible congenital flat foot 9
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil RP Oshman from
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080280
§ 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.