GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET

K122738 · Solana Surgical, LLC · HWC · Nov 7, 2012 · Orthopedic

Device Facts

• Record ID: K122738
• Device Name: GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
• Applicant: Solana Surgical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

Device Story

Gaitway Implant System is a one-piece titanium alloy implant designed for surgical placement in the sinus tarsi of the foot. Device is conical, cannulated to accept a guide wire, and available in five sizes (6.5 mm to 11.5 mm). Intended for single-use, long-term implantation (>30 days). Operates by physically blocking excessive subtalar joint pronation and talar displacement. Used by orthopedic surgeons in a clinical/surgical setting. Provides mechanical stabilization to treat hyperpronated foot and associated sequelae.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

One-piece titanium alloy implant; conical shape; cannulated for guide wire; available in 5 sizes (6.5-11.5 mm). Mechanical fixation device. No software or electronic components.

Indications for Use

Indicated for patients with hyperpronated foot requiring subtalar joint stabilization to block forward/medial talar displacement and excessive pronation.

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

• Memometal SubFix Arthroereisis Implant (K093820)
• Instratek, INC. Sub-Talar Lok, Model 7-11 mm (K080280)
• Arthrex Pro Stop Plus (K071456)

Submission Summary (Full Text)

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K122738 (pg. i of 2.)

## Section 5. - 510(k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared: Applicant: August 31, 2012 Solana Surgical, LLC 6363 Poplar Ave, Suite 434 Memphis, TN 38119 Phone: [phone] Fax: [phone] Contact: Rebecca Wahl

Common Name: Device Trade Name: Device Classification Name:

Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Devices:

Subtalar Arthroereisis Implant Gaitway Implant System Smooth or threaded metallic bone fixation fastener. Class II Orthopedic 21 CFR 888.3040 HWC K093820 Memometal SubFix Arthroereisis Implant K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K071456 Arthrex Pro Stop Plus

### Device Description:

The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.

#### Indications for use:

The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

#### Summary Comparison to Predicate Devices:

The Solana Surgical device is similar to the Memometal Subfix™ Subtalar Arthroereisis Implant (K093820), the Instratek, Inc. Sub-Talar Lok, Model 7-11 mm (K080280) and the Arthrex Pro Stop Plus (K071456). Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation. The Memometal and Instratek devices are made of titanium alloy and the Arthrex device is made of Poly L - Lactide (PLLA). The Solana Surgical, Memometal, Instratek and Arthrex devices are conical in shape so as to fit into the anatomy of the sinus tarsi. Each system is cannulated to accept a guide wire for ease of Solana Surgical - October 18, 2012

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)4122738

implantation. All devices are: intended for single use only; intended for surgical implantation longer than 30 days; are placed into the subtalar sinus tarsi.

Indications for use, geometry and material composition were considered in evaluating safety and effectiveness relative to predicate devices. The subject device is constructed of material that is identical to the Memometal and Instratek devices and greatly exceeds the mechanical strength characteristics of the Arthrex device. Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

## Letter Dated: November 7, 2012

Solana Surgical, LLC % Rebecca Wahl Vice President Research and Development 6363 Poplar Ave. Suite 434 Memphis, Tennessee 38119

Re: K122738

Trade/Device Name: Gaitway 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: August 31, 2012 Received: September 6, 2012

Dear Ms. Wahl:

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 for ass stated in the energean of 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 or any 1 ederal statute and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Wahl

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device thated adverse overse (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 rr you acce//www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation emailing 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

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): _ | 122738 Device Name: Gaitway Implant System Indications for Use:

The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated The Solana Surgical EDC, Guttway implants of earling of the marked to block forward and 1001 and Submize the Subanar John. 11-19-19-19-19 to and the resulting sequela.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

1122738 510(k) Number _

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