OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM

K111326 · Graham Medical Technologies, LLC · HRS · Jul 6, 2011 · Orthopedic

Device Facts

• Record ID: K111326
• Device Name: OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM
• Applicant: Graham Medical Technologies, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Jul 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoWedge™ Opening 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

OsteoWedge™ is a metallic bone fixation system consisting of locking plates and screws; designed for stabilization and correction of angular deviations in foot bones (e.g., first metatarsal cuneiform joint). System utilizes a screw-to-plate locking mechanism to secure the plate to prepared bone surfaces. Available in six wedge sizes with two screw diameters. Intended for use by surgeons in clinical settings. Provides mechanical stabilization to facilitate bone healing and alignment correction. Benefits include structural support for osteotomy procedures.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical bench testing including static and dynamic four-point bending, torsion testing, self-tapping performance, axial pullout testing, and insertion/removal testing.

Technological Characteristics

Metallic bone fixation system; includes plates and screws with screw-to-plate locking mechanism. Available in six wedge sizes and two screw diameters. Provided non-sterile; requires cleaning and sterilization prior to use. Mechanical fixation principle.

Indications for Use

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

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

• Low Profile Plate and Screw System (K052614)
• DARCO Locking Bone Plate System (K061808)

Submission Summary (Full Text)

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Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System

- 6 -2011 .. Jul

## Section 5 - 510(k) Summary

## Submission Correspondent

Emergo Group, Inc. www.emergogroup.com/

#### Address

611 West 5th Street, Third Floor Austin, TX 78701

## Phone

[phone]

# Fax

[phone]

# Contact

Julie Powell [e-mail]

## Submission Sponsor

Graham Medical Technologies, L.L.C. (d.b.a. GraMedica) 16137 Leone Drive Macomb, MI 48042 Tel: [phone] Fax: [phone] FDA Establishment Registration #: 3004993707

#### Date Prepared

June 30, 2011

## Trade Name

OsteoWedge™ Opening Wedge Bone Locking System

# Classification Name

Plate, Bone, Fixation

# Regulation Number

888.3030

# Product Code HRS

## Classification Panel Orthopedic

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Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System

#### Device Class

Class 2

### Device Description

The OsteoWedge™ 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 plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.

#### Intended Use

The OsteoWedge™ Opening 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.

#### Predicate Device(s)

- Arthrex, Inc., Low Profile Plate and Screw System 1.
- Darco International, Inc., DACRO Locking Bone Plate System 2.

The following table identifies and compares OsteoWedge™ Opening Wedge Bone Locking Plate System to the predicate devices with respect to 510(k) number, product code, regulation number, regulation name and indications for use.

| Manufacturer | Graham Medical<br>Technologies LLC (dba<br>GraMedica) | Darco International,<br>Inc. | Arthrex, Inc. | OsteoWedge<br>Comparison to<br>Predicates |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OsteoWedge™ Opening<br>Wedge Bone Locking<br>Plate System | DARCO Locking Bone<br>Plate System | Low Profile Plate and<br>Screw System | |
| 510(k) Number | TBD | K061808 | K052614 | NA |
| Product Code | HRS | HRS | HRS | Same |
| Regulation<br>Number | 880.3030 | 880.3030 | 880.3030 | Same |
| Regulation<br>Name | Single/multiple<br>component metallic<br>bone fixation<br>appliances and<br>accessories | Single/multiple<br>component metallic<br>bone fixation<br>appliances and<br>accessories | Single/multiple<br>component metallic<br>bone fixation<br>appliances and<br>accessories | Same |
| Indications for<br>use: | The OsteoWedge™<br>Opening Wedge Bone<br>Locking Plate System is<br>used for adult and<br>transitional adolescent<br>(18 to 21 years old)<br>patients for the<br>purpose of stabilization<br>and/or correction of<br>angular deviations<br>within an individual | The DARCO Locking<br>Bone Plate System is<br>intended for use in<br>stabilization of fresh<br>fractures, revision<br>procedures, joint<br>fusion and<br>reconstruction of<br>small bones of the<br>hand, feet, wrist,<br>ankles, fingers, and | The Arthrex Low Profile<br>Plate and Screw System<br>is intended to be used<br>for internal bone<br>fixation of bone<br>fractures, fusions, or<br>osteotomies in the<br>ankle, foot, hand, and<br>wrist, such as opening<br>wedge osteotomies of<br>Hallux Valgus. | Same patient<br>population.<br>Same use – for<br>fixation &<br>stabilization.<br>OsteoWedge is<br>indicated for<br>use only in<br>bones of foot<br>such as the first<br>metatarsal and |

# Comparison Table

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K111326 3/3

Graham Medical Technologies LLC (dba GraMedica) Traditional 510(k) Premarket Submission OsteoWedge™ Opening Wedge Bone Locking System

| Manufacturer | Graham Medical<br>Technologies LLC (dba<br>GraMedica) | Darco International,<br>Inc. | Arthrex, Inc. | OsteoWedge<br>Comparison to<br>Predicates |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------|-------------------------------------------|
| Trade Name | OsteoWedge™ Opening<br>Wedge Bone Locking<br>Plate System | DARCO Locking Bone<br>Plate System | Low Profile Plate and<br>Screw System | |
| | bone or in between<br>two adjacent bones in<br>the foot, such as<br>opening wedge<br>osteotomy for first<br>metatarsal cuneiform<br>joint deviations. | toes. The system can<br>be used in both adult<br>and pediatric patients. | | first metatarsal<br>cuneiform<br>joints. |

# Predicate Device Comparison

The OsteoWedge™ Opening Wedge Bone Locking Plate System has been compared with the Low Profile Plate and Screw System and the Locking Bone Plate System. All devices are made of the same materials, provided non sterile for cleaning and sterilization prior to use, have same indications for stabilization, and fixation, and are of similar size. The OsteoWedge™ Opening Wedge Bone Locking Plate System has slightly larger 'wedge size' and therefore has narrower 'indications for use' than that of the above predicate device, as described in above Comparison Table.

# Summary of Non-Clinical Data Submitted

The following testing has been performed to support substantial equivalence:

- Bend Testing, including Static Four Point Bending & Dynamic Four Point Bending Bending Strength
- Torsion Testing, Self-Tapping Performance, Axial Pullout Testing, and Insertion and Removal Testing
- Cleaning and Sterilization Testing

## Summary of Clinical Data Submitted

Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking Plate System. Refer to the non-clinical testing listing above to support substantial equivalence.

# Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the OsteoWedge™ Opening Wedge Bone Locking Plate System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsteoWedge™ Opening Wedge Bone Locking Plate System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

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

Graham Medical Technologies, LLC % Emergo Group, Inc. % Ms. Julie Powell 611 West 5th Street, 3rd Floor Austin, Texas 78701

JUL - 6 2011

Re: K111326

Trade/Device Name: OsteoWedge Opening Wedge Bone Locking 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: April 26, 2011 Received: May 11, 2011

Dear Ms. Powell:

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. Ilsting 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

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Page 2 -- Ms. Julie Powell

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 Pratt

Image /page/4/Picture/7 description: The image contains a handwritten letter 'f' in a cursive style. The letter is small and slightly tilted to the right. The stroke of the letter is thin and consistent, suggesting it was written with a pen or pencil.

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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# SECTION 4 - INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

### Device Name

OsteoWedge™ Opening Wedge Bone Locking Plate System

## Indications for Use

The OsteoWedge™ Opening 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.

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)

for n. Melkerson

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

510(k) Number K111326

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