•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
· The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
·The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
·The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Device Description

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

AI/ML Overview

The MaxLock Extreme® System is an orthopedic device used for bone fixation. Here's an analysis of its acceptance criteria and the study that proves its equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device (K113048)	Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence.
Safety and Effectiveness	No new issues of safety and effectiveness have been raised.
Indications for Use	The MaxLock Extreme® System has similar indications for use as the predicate device, covering various bone fracture fixations and osteotomies in adult and pediatric patients for different body regions.
Design	Similar design to the predicate device.
Materials	Similar materials (Titanium Alloy, PEEK) to the predicate device.

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

The submission states that "Finite element analysis comparing the strength of the subject and predicate devices was performed." This indicates that a physical test set of devices was not used in a clinical or benchtop comparative manner. Rather, the equivalence was demonstrated through a computational method (finite element analysis).

Test Set Sample Size: Not applicable in the traditional sense of physical devices. The "sample" here refers to the parameters and models used in the finite element analysis. The number of such models or scenarios is not specified.
Data Provenance: The finite element analysis is a computational study. Therefore, there is no country of origin for external data, and it is not retrospective or prospective in the clinical sense. The data used in the analysis would be material properties and geometric models of the devices.

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

Number of Experts: Not applicable. For a finite element analysis, "ground truth" typically refers to established engineering principles, material properties, and computational modeling standards. Experts in biomechanical engineering or materials science would be involved in performing and validating such an analysis, but they are not establishing a "ground truth" in the clinical sense (e.g., diagnosing a condition).
Qualifications of Experts: Not specified, but generally, experts conducting finite element analyses in this context would be engineers with expertise in mechanical engineering, biomechanics, and material science.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since the evaluation was based on finite element analysis, there isn't a need for expert adjudication that would be used for clinical interpretations or image assessments. The validation of the finite element model and its results would typically follow established engineering validation protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a bone fixation system, not a diagnostic imaging device. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, a standalone study (in the context of an algorithm's performance without human intervention) was not conducted. The evaluation method was a finite element analysis comparing the mechanical strength of the new device to a predicate device, not an algorithmic performance assessment.

7. Type of Ground Truth Used

Ground Truth Type: Not applicable in the clinical sense. For the finite element analysis, the "ground truth" relies on established engineering principles, validated material properties, and the accuracy of the computational models used to represent the devices and the forces they would experience. The aim was to demonstrate equivalent mechanical performance.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. Finite element analysis is not a machine learning approach that typically involves training sets. It is a simulation method based on physical laws and material properties.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of finite element analysis.

Summary

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K122005

SEP 6 2012

510(k) SUMMARY

Submitter Information

Submitter's Name:	OrthoHelix Surgical Designs, Inc.
Address:	1065 Medina Rd, Suite 500
	Medina, Ohio 44256
Telephone Number:	330-869-9562
Fax Number:	330-247-1598
Prepared By:	Andy Leither
Contact Person:	Derek Lewis
Date Prepared:	7/6/12
Device Information
Trade Name:	MaxLock Extreme® System
Common Name:	Plates/Screws
Classification Name:	Plate, Fixation, Bone and Screw, Fixation, Bone
Device Classification:	Single/multiple component metallic bone fixation appliances (Class IIper 21 CFR 888.3030 and 888.3040)Panel: Orthopedic, Product Code: HRS/HWC
Predicate Device:	The MaxLock Extreme® System is equivalent to current legallymarketed devices.
Material Composition:	Titanium Alloy, PEEK
Device Description:	The MaxLock Extreme® System consists of various size plates andscrews used to stabilize and aid in the fusion or repair of fracturedbones and bone fragments. The plates are offered in different lengthsand sizes. The screws are offered in different diameters and lengths.All implantable components are manufactured from implant gradetitanium alloy or PEEK
Indications for Use:	The MaxLock Extreme® System plates and screws are indicated for thefollowing:• The MaxLock Extreme® Universal Module is indicated for use inadult or pediatric patients as indicated for pelvic, small and longbone fracture fixation and fixation of bones that have beensurgically prepared (osteotomy) for correction of deformity orarthrodesis. Indications for use include internal fixation of the tibia,fibula, femur, humerus, ulna, radius, and bones in the hand, wrist,foot and ankle.• The MaxLock Extreme® Clavicle Module is indicated for fractures,fusions and osteotomies of the clavicle and bones in the hand,wrist, foot and ankle.• The MaxLock Extreme® Foot Module is indicated for fractures,fusions and osteotomies of bones in the hand, wrist, foot and anklein pediatric and adult patients.

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The MaxLock Extreme® Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
The new MaxLock Extreme® System is substantially equivalent to the existing OrthoHelix MaxLock Extreme® System (K113048). Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised..

Substantial Equivalence:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a symbol to the right and text to the left. The symbol is a stylized representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

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

Re: K122005

Trade/Device Name: MaxLock Extreme® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances Regulatory Class: Class II Product Code: HRS, HWC Dated: August 9, 2012 Received: August 15, 2012

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 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

SEP : 6 2012

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Page 2 - Mr. Derek Lewis

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/ReportalProblem/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 vours

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): K122005

Device Name: MaxLock Extreme® System

Indications For Use:

The MaxLock Extreme System is indicated for the following:

•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
· The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
·The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
·The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

× 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)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

Page 1 of 1

510(k) Number K122005

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.