SUB-TALAR LOK, MODEL 7-11 MM

K080280 · Instratek, Inc. · HWC · Mar 14, 2008 · Orthopedic

Device Facts

• Record ID: K080280
• Device Name: SUB-TALAR LOK, MODEL 7-11 MM
• Applicant: Instratek, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Sub-Talar Lok Implant is a cannulated, conical-shaped bone fixation fastener with external threads; designed for arthroereisis to stabilize the subtalar joint in hyperpronated feet. Implanted surgically by a physician to restrict excessive subtalar pronation in three planes; facilitates more normal joint motion. Provided in a procedure kit including dilators, implants of various sizes, and drivers. Device functions as a mechanical spacer/fixation device; no software or electronic components involved.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological comparisons to legally marketed predicate devices.

Technological Characteristics

Conical-shaped, cannulated metallic bone fixation fastener. Features external threads of uniform depth and pitch. Designed for use with a guide wire. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for patients with pathological conditions resulting from disease, injury, or trauma, specifically hypermobile pes valgus, posterior tibial tendon dysfunction, severe pronation, subtalar instability, and hypermobile flexible congenital flat foot.

Regulatory Classification

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.

Predicate Devices

• Futura Conical Subtalar Implant (K032902)
• Extremity Talar-Fit Implant (K031155)

Submission Summary (Full Text)

{0}------------------------------------------------

## SECTION 5. 510(K) SUMMARY

| Submission<br>Correspondent: | Instratek, Inc.<br>210 Spring Hill Drive<br>Suite 130<br>Spring, TX 77386<br>USA<br><br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Mr. Jeff Seavey<br>Vice President<br>MAR 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.<br>HWC at 21 CFR Part 880.3040 |
| Legally marketed device to<br>which the device is<br>substantially equivalent: | K032902, Futura Conical Subtalar Implant, Nexa Orthopedics<br>K031155, Extremity Talar-Fit Implant, Osteomed. |
| Description of the device: | The Instratek Sub-Talar Lok Implant is designed to stabilize the<br>subtalar joint of the hyperpronated foot. The implant is conical<br>shaped with external threads of uniform depth and pitch. The device<br>is cannulated for use with a guide wire. The product will be provided<br>with a procedure kit containing:<br>Five (5) dilators sized 7 through 11 mmTen Sub-Talar Lok implants, two each of five sizesRegular driver, 4.3mm hex headRescue driver, threaded |

{1}------------------------------------------------

| Intended use of the device: | The Instratek Sub-Talar Lok arthroereisis implant restricts excessive<br>subtalar pronation in all three planes, providing for a more normal<br>subtalar joint motion in patients. The Sub-Talar Lok is intended for<br>the following pathological conditions resulting from disease, injury, or<br>other trauma. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Hypermobile pes valgus |
| | • Posterior tibial tendon dysfunction |
| | • Severe pronation |
| | • Subtalar instability |
| | • Hypermobile flexible congenital flat foot |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as<br>the predicate devices. |
| Conclusions: | The results of the comparison of design, materials, intended use and<br>technological characteristics demonstrate that the device is as safe<br>and effective as the legally marketed predicate devices. |

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

## 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 implant<br>restricts excessive subtalar pronation in all three<br>planes, providing for a more normal subtalar joint<br>motion in patients. The Sub-Talar Lok is intended for<br>the 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