•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and 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

Here's an analysis of the provided text regarding the MaxLock Extreme® System, focusing on the acceptance criteria and the study used to demonstrate it:

Summary of Acceptance Criteria and Device Performance for MaxLock Extreme® System

The acceptance criteria for the MaxLock Extreme® System are primarily based on its substantial equivalence to a previously cleared predicate device (K122005). The study performed to demonstrate this equivalence focused on the mechanical strength of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Substantial Equivalence	Equivalence to predicate device (K122005) in terms of indications, design, and materials.	"The new MaxLock Extreme® System is substantially equivalent to the existing OrthoHelix MaxLock Extreme® System (K122005)."	This is a regulatory declaration based on the comparison made.
Mechanical Strength	Strength comparable to the predicate device.	"Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence."	No specific quantitative values (e.g., yield strength, fatigue life) are provided in the summary, just the conclusion that the analysis supports equivalence.
Safety and Effectiveness	No new issues of safety and effectiveness raised compared to the predicate.	"No new issues of safety and effectiveness have been raised."	This is a qualitative statement based on the comparison and lack of identified concerns.
Indications for Use	Match the indications of the predicate device (or be a justifiable expansion).	The indications for use listed for the MaxLock Extreme® System align with the general uses for bone fixation plates and screws in various anatomical locations (pelvis, small/long bones, clavicle, foot, distal radius).	The phrasing "Due to similarities in indications, design, and materials, no other testing was required" implies alignment.

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

Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial. The "test set" for this clearance was a Finite Element Analysis (FEA) model of the device. There's no mention of in-vivo or ex-vivo physical testing on a sample of devices.
Data Provenance: The data provenance is internal to the manufacturer (OrthoHelix Surgical Designs, Inc.) as it's based on their FEA and design comparisons. Country of origin for the model/analysis is not explicitly stated but would be presumed to be where OrthoHelix operates (USA). The study is retrospective in the sense that it relied on existing information about the predicate device for comparison.

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

Experts for Ground Truth: Not applicable. For an FEA study comparing mechanical strength for substantial equivalence, the "ground truth" would be the engineering principles and material properties used in the simulation, along with established standards for bone fixation devices (though specific standards aren't cited in this summary). The review and approval by the FDA (specifically the Division of Orthopedic Devices at CDRH) implicitly involves expert review of the submitted data. However, there's no mention of external clinical experts establishing "ground truth" for the FEA itself.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical or reader-based test set requiring adjudication. The FDA's review process itself acts as an adjudication body for the submitted technical data.

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

MRMC Study: No. This type of study is typically done for imaging or diagnostic devices where human readers interpret results. The MaxLock Extreme® System is a mechanical implant, and the clearance was based on engineering analysis.

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

Standalone Study: Yes, in a way. The "study" performed was a Finite Element Analysis (FEA), which is an independent, algorithm-based simulation of the device's mechanical behavior. An FEA is a computational method that doesn't involve human-in-the-loop performance in the same way an AI diagnostic tool would. It's a "standalone" engineering simulation.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this clearance relies on:
- Engineering principles and material properties: Used in the FEA to model the mechanical behavior of both the subject and predicate devices.
- Predicate device characteristics: The established mechanical performance and safety profile of the legally marketed predicate device (K122005) served as the benchmark.
- Regulatory criteria for substantial equivalence: The FDA's definition and requirements for demonstrating that a new device is as safe and effective as a predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This was not a machine learning or AI-based device requiring a training set. The FEA uses design parameters and material properties as its input, rather than a "training set" of data in the AI sense.

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

Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of an AI/ML algorithm.

Summary

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510(k) SUMMARY

DEC 1 4 2012

Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:

Device Information

Trade Name:

Common Name:

Classification Name:

Device Classification:

Predicate Device:

Material Composition:

Device Description:

Indications for Use:

OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Medina, Ohio 44256 330-869-9562 330-247-1598 Andy Leither Derek Lewis 12/12/12

MaxLock Extreme® System

Plates/Screws

Plate, Fixation, Bone and Screw, Fixation, Bone

Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030 and 888.3040) Panel: Orthopedic, Product Code: HRS/HWC

The MaxLock Extreme® System is equivalent to K122005.

Titanium Alloy, PEEK

The MaxLock Extreme® System plates and screws are 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 and 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.

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Substantial Equivalence:

The new MaxLock Extreme® System is substantially equivalent to the existing OrthoHelix MaxLock Extreme® System (K122005). 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.

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

Letter dated: December 14, 2012

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

Re: K123203

Trade/Device Name: MaxLock Extreme® 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, HWC Dated: November 26, 2012 Received: November 11, 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

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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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known):

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 and 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)

Krishna Asundi
Division of Orthopedic Devices

Page 1 of

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.