osteo-WEDGE II ® Open Wedge Bone Locking Plate System

K162179 · Graham Medical Technologies, LLC Dba Gramedica · HRS · Jan 10, 2017 · Orthopedic

Device Facts

• Record ID: K162179
• Device Name: osteo-WEDGE II ® Open Wedge Bone Locking Plate System
• Applicant: Graham Medical Technologies, LLC Dba Gramedica
• Product Code: HRS · Orthopedic
• Decision Date: Jan 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The osteo-WEDGE II® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

Device Story

Bone fixation system comprising metallic plates and screws; incorporates screw-to-plate locking mechanism. Used by surgeons in clinical settings for stabilization/correction of angular bone deviations in foot. Plate attached to prepared bone surface using six screws. Fully threaded screws available in multiple diameters/lengths. Device provides mechanical stabilization to bone segments post-osteotomy. Benefits include structural support during bone healing process.

Clinical Evidence

Bench testing only. Static and dynamic four-point bending testing performed per ASTM F382-99(2008) to demonstrate mechanical equivalence of modified plate geometry.

Technological Characteristics

Metallic bone fixation plates and screws; screw-to-plate locking mechanism. Mechanical testing per ASTM F382-99(2008).

Indications for Use

Indicated for adult and transitional adolescent (18-21 years) patients requiring stabilization or correction of angular bone deviations in the foot, specifically opening wedge osteotomy for first metatarsal cuneiform joint deviations.

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

• osteo-WEDGE® Opening Wedge Bone Locking Plate System (K111326)
• DARCO Locking Bone Plate System (K061808)

Submission Summary (Full Text)

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

Graham Medical Technologies, L.L.C. dba GraMedica January 10, 2017 % Linda Braddon President/CEO Secure Biomed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K162179 Trade/Device Name: Osteowedge II Open Wedge Bone Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS Dated: December 2, 2016 Received: December 5, 2016

Dear Ms. Braddon:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K162179

Device Name

OsteoWedge™ II Open Wedge Bone Locking Plate System

Indications for Use (Describe)

The osteo-WEDGE II ® Open Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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In accordance with 21 CFR 807.87 (h) and 21 CFR 807.92, the 510(k) summary for the GraMedica osteo-WEDGE® Opening Wedge Bone Locking Plate System is provided below.

| Date Summary Prepared | August 3, 2016 |
|---------------------------------------------------|----------------------------------------------------------------------------------------|
| Sponsor | GraMedica |
| | 16137 Leone Drive |
| | Macomb, MI 48042 |
| | 586-677-9600 (office) |
| | 586-677-9615 (fax) |
| | [e-mail] (email) |
| 510(k) Contact | Secure BioMed Evaluations |
| | Linda Braddon, Ph.D. |
| | 7828 Hickory Flat Highway |
| | Suite 120 |
| | Woodstock, GA 30188 |
| | 770-837-2681 (direct) |
| | 855-MED-DEV1 (office) |
| | [e-mail] |
| Trade Name | osteo-WEDGE II® Open Wedge Bone Locking Plate System |
| Common Name | Plate, Fixation, Bone |
| Code -Classification | HRS 21 CFR 888.3030 : Class II |
| Predicate Devices | K111326 Graham Medical Technologies LLC (dba GraMedica) osteo-WEDGE® Opening |
| | Wedge Bone Locking Plate System |
| Additional Predicate<br>Devices | K061808 DARCO Locking Bone Plate System |
| Device Description | The osteo-WEDGE II® Open Wedge Bone Locking Plate System consists of plates |
| | and screws and incorporates a screw-to-plate locking mechanism. The plate is |
| | attached to a prepared surface of the involved bone(s) of the foot using six (6) |
| | screws for fixation. The fully threaded screws are available in 2 diameters, with |
| | numerous lengths and previously cleared under K111326. |
| | |
| Intended Use | The osteo-WEDGE II® Open Wedge Bone Locking Plate System is used for adult and |
| | transitional adolescent (18 to 21 years old) patients for the purpose of stabilization |
| | and/or correction of angular deviations within an individual bone or in between |
| | two adjacent bones in the foot, such as opening wedge osteotomy for first |
| | metatarsal cuneiform joint deviations. |
| Technological | The osteo-WEDGE II® Open Wedge Bone Locking Plate System is of similar sizes, |
| Characteristics | material choices and configurations as compared to the predicate. |
| Non-Clinical<br>Performance Testing<br>Conclusion | Non-clinical testing was performed to demonstrate the change of the plate |
| | geometry is substantially equivalent to other predicate devices. The following |
| | tests were performed: |
| | ● Static and dynamic four-point bending testing per ASTM F382-99(2008) |
| Substantial Equivalence<br>Summary (Conclusion) | Based on the indications for use, technological characteristics, and comparison to |
| | predicate devices, the osteo-WEDGE II® Open Wedge Bone Locking Plate System is |
| | shown to be substantially equivalent to legally marketed predicate devices. |