Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Device Description

This special 510(K) submission is a modification to the previously cleared Modular Foot and Clavicle systems to add a variable angle locking screw construct. No changes have been made to the current locking plates; this addition will be compatible with all plates currently in the system. The OrthoHelix variable angle construct consists of a polymer ring which mates with the locking plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.

AI/ML Overview

The provided text describes a medical device, the MaxLock Extreme® Extremity Plating System with Variable Angle Technology, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a performance study with metrics like sensitivity, specificity, or accuracy.

Instead, the acceptance criteria and proof of their fulfillment for this type of device (bone fixation system) are primarily based on mechanical testing demonstrating substantial equivalence to previously cleared devices.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	Dynamic mechanical testing (e.g., fatigue, stability)	Dynamic mechanical testing confirmed substantial equivalence to predicate devices.
	Static mechanical testing (e.g., strength, stiffness)	Static mechanical testing confirmed substantial equivalence to predicate devices.
Material Equivalence	Materials are equivalent to predicate devices.	"No changes have been made to the current locking plates." (Implies material consistency with cleared plates). Introduction of a "polymer ring" and "specially designed locking screw" implies these new components also meet relevant material and performance standards, though specific data is not detailed here.
Performance vs. Predicate	Performance is substantially equivalent to predicate devices for intended use.	"Dynamic and static mechanical testing confirm that the MaxLock Extreme® implants with Variable Angle Technology are substantially equivalent to their predicate and meet the specified requirements for their intended use."
Safety and Efficacy	No new issues of safety and efficacy are raised.	"No new issues of safety and efficacy have been raised during the development of this system."

Study Details (Mechanical Testing)

Sample size used for the test set and the data provenance:
- The text does not specify the exact sample size (number of implants tested) for the dynamic and static mechanical testing.
- Data Provenance: The testing was conducted by OrthoHelix Surgical Designs Inc., a US-based company, as part of their development process for this modification. This would be considered prospective data generation for the purpose of demonstrating device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of mechanical testing does not typically involve "experts" establishing a "ground truth" in the same way clinical or diagnostic studies do. The "ground truth" here is adherence to established engineering and mechanical testing standards (e.g., ASTM standards for orthopedic implants), which are often industry-accepted benchmarks for performance. Product engineers and test lab personnel would conduct and assess these tests.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or image-based ground truth, not for mechanical testing results. Mechanical test results are quantitative and compared directly to specified performance metrics or predicate device performance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical implant, not an algorithm.
The type of ground truth used:
- For mechanical testing, the "ground truth" is defined by established engineering standards and the performance of the predicate devices. The new device's performance is compared against these benchmarks to establish substantial equivalence.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
How the ground truth for the training set was established:
- Not applicable.

Summary

{0}------------------------------------------------

APR 2 0 2010

KI00618 (1)2)

510(K) Summary of Safety and Effectiveness MaxLock Extreme® Extremity Plating System with Variable AngleTechnology

Class II

Proprietary Name:

MaxLock Extreme Extremity Plating System with Variable Angle Technology

888.3030 - Single/multiple component metallic

HRS - Single/multiple component metallic bone

bone fixation appliances and accessories

fixation appliances and accessories

Common Name:

Bone Fixation Screws

Classification Name and Reference:

Regulatory Class:

Device Product Code:

Contact Information:

Derek Lewis Vice-President of Research and Development OrthoHelix Surgical Designs Inc. 1065 Medina Rd., Suite 500 Medina. OH 44256 Phone: 330 869-9562 Fax: 330 247-1598 E-Mail: dlewis@orthohelix.com

Summary Date:

April 15, 2010

Device Description

{1}------------------------------------------------

Intended Use

Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Substantial Equivalence

The MaxLock Extreme® Extremity Plating System with Variable Angle Technology is substantially equivalent to currently marketed devices, the OrthoHelix Modular Foot System (K073624) and Clavicle Plating System (K090289) and the Stryker VariAx System (K060613). The new technology is a modification to the OrthoHelix Modular Foot System, K073624 and Clavicle Plating System, K090289. The new technology only differs from the predicate devices with inclusion of a polymer locking ring and a specially designed locking screw to facilitate a variable angle locking mechanism.

Dynamic and static mechanical testing confirm that the MaxLock Extreme® implants with Variable Angle Technology are substantially equivalent to their predicate and meet the specified requirements for their intended use. No new issues of safety and efficacy have been raised during the development of this system.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

APR 2 0 2010

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

OrthoHelix Surgical Designs, Inc. % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K100618

Trade/Device Name: MaxLock Extreme® Extremity Plating System with Variable Angle Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS Dated: April 5, 2010 Received: April 6, 2010

Dear Mr. Lewis:

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

{3}------------------------------------------------

Page 2 - Mr. Derek Lewis

CFR Part 807): labeling (21 CFR Part 801); medical device 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/CDRH0ffices/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.

Barbara buchner

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): ID KIOO6 18

Device Name: MaxLock Extreme Extremity Plating System with Variable Angle Technology

Indications for Use:

: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Prescription Use X (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)

Page of

Sonita fr mxm
(Division Sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number _

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.