NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

K111799 · Ascension Orthopedic · HWC · Aug 19, 2011 · Orthopedic

Device Facts

• Record ID: K111799
• Device Name: NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
• Applicant: Ascension Orthopedic
• Product Code: HWC · Orthopedic
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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 NuGait Subtalar Implant System implants are intended for single use only.

Device Story

NuGait Subtalar Implant System is a one-piece arthroereisis implant designed to stabilize the subtalar joint in hyperpronated feet. Implant is inserted into the sinus tarsi to restrict excessive pronation in downward, forward, and medial planes. Device is cannulated for precise insertion over a guide wire using system-specific instrumentation. Used by orthopedic surgeons in a clinical/surgical setting. Implant features a helical thread for fixation. Benefits include restoration of more normal subtalar joint motion. Single-use device.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, specifically bending strength evaluation.

Technological Characteristics

Constructed of Ti-6Al-4V ELI titanium alloy. One-piece, cannulated design with helical outer thread for fixation. Offered in 5 sizes. Sterilized via gamma radiation. Single-use.

Indications for Use

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

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

• Sub-Talar Lok Arthroereisis Implant System (K080280)

Submission Summary (Full Text)

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ascension orthopedics, inc .8700 Cameron Road, Suite 100 AUSTIN, TEXAS 78754

## Summary of Safety and Effectiveness

Summary of Safety and Effectiveness

| Sponsor: | Ascension Orthopedics, Inc.<br>8700 Cameron Road, Suite 100<br>Austin, TX 78754-3832<br>AUG 19 2011 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bradley W. Strasser<br>Regulatory Affairs Specialist<br>512-836-5001 ext. 1541 |
| Date: | 24 June 2011 |
| Trade Name: | <i>NuGait</i> ™ Subtalar Implant System |
| Common Name: | Subtalar Arthroereisis Implant |
| Product Code: | HWC - Screw, Fixation, Bone |
| Classification: | 21 CFR §888.3040 - Smooth or threaded metallic bone fixation fastener. |
| Panel: | Orthopedic |
| Predicate Device: | <i>Sub-Talar Lok</i> ™ Arthroereisis Implant System; K080280, cleared 14 March 2008; manufactured by Instratek, Inc. |
| Device Description: | The <i>NuGait</i> Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The <i>NuGait</i> implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each <i>NuGait</i> is packaged individually and sterilized via gamma radiation. These devices are intended for single use only. |

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Intended Use: The NuGait Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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. Basis of Substantial Equivalence: The NuGait Subtalar Implant System has the same technological characteristics and intended use as the predicate device. The subject device is also manufactured from equivalent materials. These points and engineering analysis form the basis for substantial equivalence, and the differences between the subject device and predicate do not raise new issues of safety or effectiveness. Non-Clinical Performance Data: In order to support substantial equivalence, the following non-clinical performance data was gathered: . Bending Strength Evaluation Clinical Performance Data: Clinical performance data were not needed for this

device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ascension Orthopedies, Inc. % Mr. Bradley W. Strasser 8700 Cameron Road, Suite 100 Austin, TX 78754-3832

AUG 1 9 2011

Re: K111799

Trade/Device Name: NuGaif™ Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 24th, 2011 Received: June 27th, 2011

Dear Mr. Strasser,

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.

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Page 2 - Mr. Bradley W. Strasser

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 device-related 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://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 note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric P. Kettl

مرحم Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K 111799

## Device Name:

NuGait™ Subtalar Implant System

## Indications for Use:

The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System 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 NuGait Subtalar Implant System implants are intended for single use only.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (ODE)

for M. Melkerm

(Division Sigh Off) Division of Surgical, Orthopedic, and Restorative Devices

10(k) Number K111799

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