IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION

K092381 · Ibalance Medical, Inc. · HRS · Oct 27, 2009 · Orthopedic

Device Facts

• Record ID: K092381
• Device Name: IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
• Applicant: Ibalance Medical, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iBalance AKRFx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.

Device Story

System provides fixation for proximal tibial opening wedge osteotomies; comprises instrumentation set, PEEK wedge-like implant, and PEEK cancellous/cortical anchors. Surgeon uses instrumentation to perform osteotomy and place implant/anchors; components function as single construct to fixate and support wedge at corrective angle. Used in clinical/surgical setting. Benefits patient by stabilizing bone during healing process following corrective surgery.

Clinical Evidence

Bench testing (ASTM F 2077) compared physical properties to predicate. Cadaver studies validated instrumentation performance for implant/anchor placement. Clinical safety study demonstrated no adverse effects on osteotomy healing compared to predicates.

Technological Characteristics

System includes PEEK wedge implant and PEEK anchors. Materials meet ISO 10993-1 (biocompatibility) and ASTM F 899 (stainless steel for instrumentation). Mechanical performance tested per ASTM F 2077. Implant available in three sizes (SM, MD, LG).

Indications for Use

Indicated for patients undergoing proximal tibial opening wedge osteotomies requiring fixation. Intended for use with post-operative immobilization.

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

• Arthrex, Inc.'s Titanium Opening Wedge Osteotomy System (K032187)
• Spine Wave, Inc.'s Wafer System (K033303)
• Synthes Spiked Washer (K011583)
• Cayenne AperFix Interference Screw (K073426)
• Cayenne AperFix Implant (K083607)

Submission Summary (Full Text)

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# 510(k) Summary

#### iBalance Medical, Inc.'s AKRyx Medial Opening Wedge Tibial System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

iBalance Medical, Inc. 4900 Nautilus Court, Ste 100 Boulder, CO 80301 Phone: [phone] Facsimile: 303-530-0530

OCT 2 7 2009

Contact Person: Kelly Ammann

Date Prepared: August 4, 2009

Name of Device and Name: AKREx Medial Opening Wedge Tibial System

Common or Usual Name: Opening Wedge Osteotomy device

Classification Name: Bone fixation appliances and accessories

#### Predicate Devices

Arthrex, Inc.'s Titanium Opening Wedge Osteotomy System (K032187) Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (K011583) Cayenne AperFix Interference Screw (K073426) Cayenne AperFix Implant (K083607)

#### Intended Use / Indications for Use

The iBalance AKRFX Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.

#### Technological Characteristics

The iBalance AKRFx Medial Opening Wedge Tibial System is comprised of an instrumentation set (AKRFX Medial Instrumentation), a PEEK wedge-like implant (the iFX® Medial PEEK Implant) and PEEK fixation (the iFX® Medial PEEK Cancellous and Cortical Anchors). The system enables surgeons to perform a high tibial opening wedge osteotomy with fixation.

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K092381 2/2

## 510(k) Summary

The iFX® Medial PEEK Implant is provided in three general sizes; Small (SM), Medium (MD), and Large (LG). Two configurations of implant and anchors exist. The implant and anchors work as a single construct to fixate and support the opening wedge at its corrective angle.

#### Performance Data

Biomaterials in the AKREX Medial Opening Wedge Tibial System meet standard ISO 10993-1 standard for biocompatibility or ASTM F 899 for stainless steel. Performance testing according to ASTM F 2077 compared physical properties of the iBalance AKREX System to the Arthex System predicate device. In addition, cadaver studies demonstrated the performance of the AKREx Instrumentation cnables the proper placement of the iFX implant and anchors. Lastly, the company's clinical safety study shows that the differences in the iFX® Medial PEEK Implant System do not raise new safety issues and healing of the osteotomy is not adversely affected by differences in device design as compared to the predicates.

In all instances, the iBalance AKRFX Medial Opening Wedge Tibial System functioned as intended and testing results observed were as expected.

#### Substantial Equivalence

The iBalance AKREX Medial Opening Wedge Tibial System is as safe and effective as the identified predicate devices. The iBalance AKREX Medial Opening Wedge Tibial System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the iBalance AKREx Medial Opening Wedge Tibial System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the iBalance AKRpx Medial Opening Wedge Tibial System is as safe and effective as the identified predicate devices. Thus, the iBalance AKREx Medial Opening Wedge Tibial System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

iBalance Medical. Inc. % Hogan & Hartson LLP % Ms. Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103

OCT 2 7 2009

Re: K092381

Trade/Device Name: iBalance AKRFx Medial Opening Wedge Tibial System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 4, 2009 Received: August 5, 2009

Dear Ms. Hogan:

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.

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Janice M. Hogan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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):

Device Name: iBalance® AKRFx Medial Opening Wedge Tibial System

Indications for Use:

"The iBalance AKRxx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies.

It is intended to be used with adequate post-operative immobilization."

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omite for Mxm

(Division Sign-0 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092381

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