ADAPTIVE WEDGE

K110662 · Adaptive Specialty, LLC · HRS · Mar 12, 2012 · Orthopedic

Device Facts

• Record ID: K110662
• Device Name: ADAPTIVE WEDGE
• Applicant: Adaptive Specialty, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Mar 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as: - opening wedge osteotomies of Hallux Valgus . - · Evans lengthening osteotomies - · Cotton osteotomy This device is intended for use with ancillary fixation and is not intended for use in the spine.

Device Story

Adaptive Wedge is a bone fixation implant for small bones in the ankle and foot. Device features angular teeth to prevent migration and is available in various widths/thicknesses to accommodate anatomical variations. Implanted by surgeons during orthopedic procedures to correct bony voids or gaps; requires ancillary fixation. Device facilitates bony integration. Benefits include structural support for osteotomies and fractures. No software or electronic components.

Clinical Evidence

No clinical studies were performed. Equivalence is supported by non-clinical bench testing, including static and dynamic compression, coefficient of friction, and subsidence/debris generation testing.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026) and Titanium alloy (ASTM F136). Design: Angular teeth for fixation. Form factor: Varying widths and thicknesses for small bone applications. No software, electronics, or energy sources.

Indications for Use

Indicated for internal bone fixation for small bone fractures or osteotomies in the ankle and foot, including Hallux Valgus opening wedge, Evans lengthening, and Cotton osteotomies. Not for use in the spine. Requires ancillary fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• BIOFOAM™ Bone Wedge (K073535 / K093950)

Submission Summary (Full Text)

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<110 662

MAR 1 2 2

## 510(k) Summa for the Adaptive Wedge

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for the Adaptive Wedge

Date Prepared: March 2, 2011

| 1. Submitter: | Adaptive Specialty LLC |
|-----------------|----------------------------|
| | 25 NW 23rd PL, STE 6-347 |
| | Portland, OR 97210 |
| | [phone] Tele |
| | [phone]Fax |
| Contact Person: | J.D. Webb |
| | The OrthoMedix Group, Inc. |
| | 1001 Oakwood Blvd |
| | Round Rock, TX 78681 |
| | Telephone: [phone] |

- 2. Trade name: Adaptive Wedge Common Name: Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS Class II
- ന് Predicate or legally marketed devices which are substantially equivalent: BIOFOAM™ Bone Wedge (K073535 / K093950)

#### Description of the device: 4.

The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in varying widths and thicknesses to accommodate a variety of small bone applications.

### Materials:

PEEK Optima LT1 per ASTM F2026. Titanium alloy per ASTM F136.

### Function:

Used for angular correction of gaps and bony voids of small bones in the ankle and foot.

#### 5. Substantial equivalence claimed to predicate devices

The Adaptive Wedge is substantially equivalent to the BIOFOAM™ Bone Wedges in terms of intended use, design, mechanical safety and performance.

#### 6. Intended Use:

The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:

- opening wedge osteotomies of Hallux Valgus .
- · Evans lengthening osteotomies
- · Cotton osteotomy

This device is intended for use with ancillary fixation and is not intended for use in the spine.

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//066.2

se. 2/2

## 7. Non-clinical Test Summary:

The following tests were conducted:

- . Static compression testing
- . Dynamic compression testing
- . Determination of the coefficient of friction
- Determination of subsidence and debris generation during static and dynamic . compression-shear testing

The results of this testing indicate that the Adaptive Wedge is equivalent to predicate devices.

## 8. Clinical Test Summary

No clinical studies were performed

#### 9. Conclusions Nonclinical and Clinical

The conclusions drawn from the comparison between the devices demonstrate that the Adaptive Wedge is as safe, as effective, and performs as well as, or better, than the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized representation of a human figure. The figure is composed of three abstract shapes, possibly representing the head, body, and legs, and is oriented towards the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAR 1 2 2012

Adaptive Specialty LLC % Mr. J.D. Webb The OrthoMedix Group, Inc 1001 Oakwood Blvd Round Rock, TX 78681

### Re: K110662

Trade/Device Name: Adaptive Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS Dated: February 29th, 2012 Received: March 7th, 2012

### Dear Mr. Webb:

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. J.D. Webb

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,

Per Doth

Mark N. Melkerson Dep Car Dis 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): K110662

Device Name: _ Adaptive Wedge

Indications for Use:

The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:

- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies .
- · Cotton osteotomy

This device is intended for use with ancillary fixation and is not intended for use in the spine.

Prescription Use X (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)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110662