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 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.

AI/ML Overview

The OsteoWedge™ Opening Wedge Bone Locking System is a medical device used for stabilizing and/or correcting angular deviations in the bones of the foot. Its acceptance was based on demonstrating substantial equivalence to predicate devices, namely the Arthrex, Inc. Low Profile Plate and Screw System and the Darco International, Inc. DACRO Locking Bone Plate System.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OsteoWedge™ system were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This involves showing that the new device has the same intended use and technological characteristics as the predicate devices, or if it has different technological characteristics, that it does not raise different questions regarding its safety and effectiveness.

The reported device performance is implicitly that it meets the safety and effectiveness profile equivalent to the predicate devices.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use Equivalence	The OsteoWedge™ system must have the same intended use as the predicate devices. This includes the patient population (adult and transitional adolescent patients, 18-21 years old) and the purpose (stabilization and/or correction of angular deviations within an individual bone or between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations).	The OsteoWedge™ system's intended use is 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." This was deemed comparable to the predicates, which are also used for stabilization and fixation in foot bones. Although OsteoWedge has a narrower indication (foot only) compared to some predicates (hand, feet, wrist, ankles, fingers, and toes), this difference was not considered to raise new questions of safety or effectiveness.
Technological Characteristics Equivalence	The device should share similar technological characteristics with the predicate devices, including materials, design principles, screw-to-plate locking mechanisms, and provision as non-sterile for cleaning and sterilization. Deviations in size should be justified not to impact safety or effectiveness negatively.	Materials: All devices are made of the "same materials." Sterilization: All devices are "provided non sterile for cleaning and sterilization prior to use." Function/Mechanism: All devices are for "fixation & stabilization" and incorporate a screw-to-plate locking mechanism. Size: The OsteoWedge™ has "slightly larger 'wedge size'" than the predicate devices, but this was justified as leading to "narrower 'indications for use'" and not raising new safety/effectiveness questions.
Safety and Effectiveness	The device must not raise different questions regarding its safety and effectiveness compared to the predicate devices. This is typically supported by non-clinical performance testing.	Non-Clinical Testing: The following tests were performed: - Bend Testing (Static Four Point Bending & Dynamic Four Point Bending) - Bending Strength - Torsion Testing - Self-Tapping Performance - Axial Pullout Testing - Insertion and Removal Testing - Cleaning and Sterilization Testing Conclusion: The submission states 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."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a "test set" in the context of clinical data or patient samples. The submission relies on non-clinical (bench) testing to support substantial equivalence.

Sample Size for Test Set: Not applicable in the context of clinical data. The sample sizes would refer to the number of devices or components tested during the non-clinical mechanical and sterilization tests, but these specific numbers are not provided in the summary.
Data Provenance: Not applicable for clinical data. The non-clinical testing was conducted to evaluate the device's physical properties and performance against engineering standards. The location or specific context of these non-clinical tests is not detailed beyond being "performed to support substantial equivalence."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission did not rely on clinical data, expert consensus, or ground truth established by medical experts for a "test set" to prove device performance in a diagnostic or clinical efficacy manner. The assessment was based on engineering and performance characteristics relative to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking System." Since no clinical trials were done, an MRMC study was certainly not performed, and therefore, an effect size of human readers with AI assistance is not relevant.

6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical bone plate system, not an AI algorithm or diagnostic tool. The concept of "standalone performance" for an algorithm or human-in-the-loop performance is not applicable to this type of medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" refers to established engineering standards, material properties, and mechanical performance metrics (e.g., bending strength, torsion resistance, pullout strength). These are objective, measurable physical properties, not clinical outcomes or expert interpretations.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not involve AI or machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to the device submission.

Summary

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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

(512) 327-9997

Fax

(512) 327-9998

Contact

Julie Powell jpowell@emergogroup.com

Submission Sponsor

Graham Medical Technologies, L.L.C. (d.b.a. GraMedica) 16137 Leone Drive Macomb, MI 48042 Tel: 586 677 9600 Fax: 586 677 9615 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

Intended Use

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 MedicalTechnologies LLC (dbaGraMedica)	Darco International,Inc.	Arthrex, Inc.	OsteoWedgeComparison toPredicates
Trade Name	OsteoWedge™ OpeningWedge Bone LockingPlate System	DARCO Locking BonePlate System	Low Profile Plate andScrew System
510(k) Number	TBD	K061808	K052614	NA
Product Code	HRS	HRS	HRS	Same
RegulationNumber	880.3030	880.3030	880.3030	Same
RegulationName	Single/multiplecomponent metallicbone fixationappliances andaccessories	Single/multiplecomponent metallicbone fixationappliances andaccessories	Single/multiplecomponent metallicbone fixationappliances andaccessories	Same
Indications foruse:	The OsteoWedge™Opening Wedge BoneLocking Plate System isused for adult andtransitional adolescent(18 to 21 years old)patients for thepurpose of stabilizationand/or correction ofangular deviationswithin an individual	The DARCO LockingBone Plate System isintended for use instabilization of freshfractures, revisionprocedures, jointfusion andreconstruction ofsmall bones of thehand, feet, wrist,ankles, fingers, and	The Arthrex Low ProfilePlate and Screw Systemis intended to be usedfor internal bonefixation of bonefractures, fusions, orosteotomies in theankle, foot, hand, andwrist, such as openingwedge osteotomies ofHallux Valgus.	Same patientpopulation.Same use – forfixation &stabilization.OsteoWedge isindicated foruse only inbones of footsuch as the firstmetatarsal 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 MedicalTechnologies LLC (dbaGraMedica)	Darco International,Inc.	Arthrex, Inc.	OsteoWedgeComparison toPredicates
Trade Name	OsteoWedge™ OpeningWedge Bone LockingPlate System	DARCO Locking BonePlate System	Low Profile Plate andScrew System
	bone or in betweentwo adjacent bones inthe foot, such asopening wedgeosteotomy for firstmetatarsal cuneiformjoint deviations.	toes. The system canbe used in both adultand pediatric patients.		first metatarsalcuneiformjoints.

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 (800) 638-2041 or (301) 796-7100 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

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

Page 1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.