INTEGRA TITANIUM BONE WEDGE

K131360 · Ascension Orthopedic · HRS · Aug 7, 2013 · Orthopedic

Device Facts

• Record ID: K131360
• Device Name: INTEGRA TITANIUM BONE WEDGE
• Applicant: Ascension Orthopedic
• Product Code: HRS · Orthopedic
• Decision Date: Aug 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: Cotton (opening wedge) osteotomies of the medial cuneiform Evans lengthening osteotomies The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation. The Integra® Titanium Bone Wedges are not intended for use in the spine.

Device Story

Integra® Titanium Bone Wedge is a series of wedge-shaped implants for angular correction of small bones in the ankle and foot. Constructed from commercially pure titanium with a cancellous-like structure; available in various sizes/shapes. Used by orthopedic surgeons in clinical settings for internal fixation of fractures or osteotomies (e.g., Cotton, Evans). Device requires ancillary plating fixation for stability. Provides structural support to bone segments during healing; benefits patients by correcting skeletal deformities in the foot/ankle.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included expulsion, abrasion, static compression, and compressive fatigue. Biocompatibility testing was also performed to support safety.

Technological Characteristics

Commercially pure titanium; cancellous-like porous structure. Wedge-shaped form factor for small bone angular correction. Requires ancillary plating fixation. Non-active, mechanical implant.

Indications for Use

Indicated for internal bone fixation for fractures or osteotomies in the ankle and foot, specifically Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. Not for use in the spine. Requires ancillary plating 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 (K093950)

Submission Summary (Full Text)

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## 510(K) SUMMARY

## Integra® Titanium Bone Wedge

#### Submitter's name and address:

Ascension Orthopedics 8700 Cameron Road Austin, TX 78754 USA

#### Contact person and telephone number:

Kyla Kara Associate, Regulatory Affairs Telephone: [phone] Facsimile: 609.275.9445

**AUG 07 2013**

#### Date Summary was prepared:

May 9, 2013

#### Name of the device:

| Proprietary Name: | Integra® Titanium Bone Wedge |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Wedge |
| Classification Name: | Plate, Fixation, Bone (21CFR §888.3030, Product Code HRS)<br>Screw, Fixation, Bone (21CFR §888.3040, Product Code HWC) |
| Classification Panel: | Orthopedic |

#### Substantial Equivalence:

The Integra® Titanium Bone Wedge is substantially equivalent in function and intended use to the predicate device detailed in the following table.

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|--------------|------------------------|------------------------------------|
| K093950 | HRS; HWC | BIOFOAM™ Bone<br>Wedge | Wright Medical<br>Technology, Inc. |

## Device Description:

The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.

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#### Indications for Use:

The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

- Cotton (opening wedge) osteotomies of the medial cuneiform
- · Evans lengthening osteotomies

The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.

The Integra® Titanium Bone Wedges are not intended for use in the spine.

## Substantial Equivalence Comparison:

Components of the Integra Titanium Bone Wedge are similar in design and materials to the predicate device, BIOFOAM™ Bone Wedge (K093950).

## Testing and Test Results:

Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified.

#### Conclusion:

The design features, material, and intended use of the Integra® Titanium Bone Wedges are substantially equivalent to the predicate device. BIOFOAM™ Bone Wedge (K093950). The safety and effectiveness of the Integra® Titanium Bone Wedge is adequately supported by the substantial equivalence information, materials information, and performance data provided within this Premarket Notification submission.

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Public Ficalth Service

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

August 7, 2013

Ascension Orthopedies Ms. Kyla Kara Associate, Regulatory Affairs 8700 Cameron Road Austin, Texas 78754

Re: K131360

Trade/Device Name: Integra® Titanium Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: July 19, 2013 Received: July 22, 2013

Dear Ms. Kara:

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 cither 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 complics 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

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#### Page 2 – Ms. Kyla Kara

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Erin I. Keith

For

Mark N. Melkerson IDirector 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): K131360

Integra® Titanium Bone Wedge Device Name:

Indications For Use:

The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:

· Cotton (opening wedge) osteotomies of the medial cuneiform

· Evans lengthening osteotomies

The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.

The Integra Titanium Bone Wedges are 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Elizabeth L. Frank -S

Division of Orthopedic Devices

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