The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Device Description

The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.

AI/ML Overview

The OrthoPediatrics ACL Reconstruction System's performance was evaluated through mechanical testing, specifically static pull-out testing and dynamic cyclic loading, to demonstrate substantial equivalence to predicate devices. The document does not provide specific numerical acceptance criteria or detailed device performance metrics beyond stating that the system "demonstrated substantial equivalence to predicate device performance."

Here's an overview of the information you requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text, but generally would involve specific thresholds for static pull-out strength and dynamic cyclic loading characteristics to ensure adequate fixation and durability.	The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance in static pull-out testing and dynamic cyclic loading.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. Mechanical testing is typically laboratory-based, so "country of origin" would refer to the testing facility, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable. The study involved mechanical performance testing of a physical device, not interpretation of data by human experts to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable as the study involved mechanical testing, not expert interpretation requiring adjudication.

5. 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

This question is not applicable. The study was a mechanical performance evaluation of a medical device, not a human reader study involving AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The study was a mechanical performance evaluation of a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for mechanical testing is established by standardized test methods (e.g., ASTM standards) that define how force is applied and how displacement/failure is measured. The "ground truth" would be the direct measurements of mechanical properties (e.g., peak load, stiffness, cycles to failure) observed during these tests.

8. The sample size for the training set

This question is not applicable. The study did not involve a training set as it was a mechanical performance evaluation, not a machine learning model.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

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510(k) Summary

NAME OF FIRM: OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw. IN 46582

DATE PREPARED: June 10, 2013

510(K) CONTACT: Mark Fox Vice President, Regulatory Affairs Tel: (574) 268-6379 ·

MBI

PROPOSED TRADE NAME:

OrthoPediatrics ACL Reconstruction System

Fastner, Fixation, Nondegradable, Soft Tissue

DEVICE CLASSIFICATION:

Class II: 21 CFR 888.3040

CLASSIFICATION NAME: PRODUCT CODE:

DEVICE DESCRIPTION: The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.

The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic

INDICATIONS FOR USE: .

MATERIALS:

Titanium Allov per ASTM F136 PEEK Optima per ASTM F2026

Ligament (ACL) Reconstruction.

PREDICATE DEVICES:

EndoButton CL Ultra (Smith & Nephew, K980155) for the loop fixation implant. Arthrex Sheathed Cannulated Interference Screw (Arthrex, K062466) for the screw & sleeve construct.

reconstruction procedures such as Anterior Cruciate

TECHNOLOGIC The fundamental scientific principles and technological CHARACTERISTICS: characteristics, including the intended use, material, and

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general design, and sizes of the device are the same as, or similar to, the predicate devices. The OrthoPediatrics ACL Reconstruction System possesses a modified technological characteristic in that the femoral component utilizes a sleeve construct in order to prevent off axis screw tracking.

PERFORMANCE DATA:

Static pull out testing as well as dynamic cyclic loading were utilized in order to characterize the mechanical properties of the OrthoPediatrics ACL Reconstruction System. The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 20, 2013

OrthoPediatrics, Corporation % Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw. Indiana 46582

Re: K130217

Trade/Device Name: OrthoPediatrics ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 15, 2013 Received: May 16, 2013

Dear Mr. Fox:

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. Mark Fox

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Erin I. Keith

For

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

Enclosure

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7 Indications for Use Statement

510(k) Number: K130217

Device Name: OrthoPediatrics ACL Reconstruction System

Indications for Use:

The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

Prescription Use______________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-Counter Use_

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.