The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.

Device Description

The DePuy Mitek RIGIDFIX® CURVE Cross Pin System consists of instruments and Cross Pins designed for use with the RIGIDFIX® CURVE Cross Pin Instrumentation. The Soft Tissue (ST) Cross Pin material is PEEK™ (polyetheretherketone), a radiolucent high strength thermoplastic or PLA (Poly-Lactic Acid). Repair requires two (2) DePuy Mitek RIGIDFIX® CURVE Cross Pins.

AI/ML Overview

The provided documentation describes a 510(k) submission for the DePuy Mitek RIGIDFIX® CURVE Cross Pin System. This system is a medical device designed for femoral fixation of ACL soft tissue grafts.

The submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI or diagnostic devices, is not applicable to this type of submission.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Material Equivalence: The PLA implant should be identical in material and design to the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. The PEEK implant should use the same PEEK material as the predicate DePuy Mitek Gryphon PEEK Anchor and have the same dimensional specifications as the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant.	The proposed RIGIDFIX CURVE ST ACL PLA Cross Pin System implant is identical in material and design to the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant. The proposed RIGIDFIX CURVE ST ACL PEEK Cross Pin System implant is manufactured out of the same PEEK material as the predicate DePuy Mitek Gryphon PEEK Anchor and has the same dimensional specification as the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant.
Functional Equivalence (Instruments): The proposed instruments should be similar to those offered for the predicate RIGIDFIX System, with material similarity (stainless steel and radel) and the redesign allowing for fully adjustable femoral cross pin implantation.	The proposed disposable and reusable instruments are similar to those currently offered for use with the predicate RIGIDFIX System. The proposed and predicate disposable instruments are made of similar materials: stainless steel and radel. The proposed disposable instruments have been redesigned to allow the capability of being fully adjustable for desired angle of femoral cross pin implantation, which is an improvement over the predicate's 0-degree insertion limitation.
Safety and Performance: Product Design Verification activities (e.g., In-Vitro Break Strength Testing and Real-Time Break Strength Testing) should demonstrate that the proposed devices are substantially equivalent to the predicate devices in terms of performance and safety.	Results of performance and safety testing (In-Vitro Break Strength Testing and Real-Time Break Strength Testing) have demonstrated that the proposed devices are substantially equivalent to the predicate devices.

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

This information is not provided in the summary. The testing mentioned (In-Vitro Break Strength Testing and Real-Time Break Strength Testing) would involve physical samples of the device and likely would not have a "test set" in the sense of patient data.

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 information is not applicable as the submission relies on physical and material testing, not expert-derived ground truth from patient data.

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

This information is not applicable as there is no mention of a test set requiring adjudication in the context of expert review.

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 information is not applicable. This is a submission for a surgical implant system, not an AI or diagnostic imaging device.

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

This information is not applicable. This is not an AI algorithm.

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

The "ground truth" in this context is the performance and safety profiles of the legally marketed predicate devices, as established through their prior 510(k) clearances and the manufacturer's own design verification activities (e.g., break strength testing). The goal is to show that the new device meets or exceeds these established benchmarks.

8. The sample size for the training set

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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

This information is not applicable as this is not an AI or machine learning device requiring a training set.

Summary

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ATTACHMENT 1 510(k) SUMMARY

SUBMITTER'S NAME AND ADDRESS DePuy Mitek

A Johnson & Johnson Company 325 Paramount Drive Raynham, MA 02767

CONTACT PERSON

Julie Vafides Regulatory Affairs Specialist II

TELEPHONE	508-977-6645
FASCIMILE	508-977-6911
EMAIL	jvafides@its.jnj.com
DATE PREPARED:	January 14, 2013

NAME OF MEDICAL DEVICE TRADE NAME/PROPRIETARY NAME:

RIGIDFIX® CURVE ST ACL PEEK Cross Pin System RIGIDFIX® CURVE ST ACL PLA Cross Pin System

SUBSTANCIAL EQUIVALENCE

The proposed RIGIDFIX CURVE ST ACL Cross Pin System is substantially equivalent to the following devices:

. K974341
RIGIDFIX Femoral 3.3 mm ST Cross Pin Kit (PLA)
. K090669, K091041 RIGIDFIX Biocryl 3.3 mm Femoral ST Cross Pin Kit
Gryphon PEEK Anchor K103712 �

DEVICE CLASSIFICATION

PLA Implants: Single/multiple component metallic bone fixation appliances and accessories, classified as Class II, product code MAI, regulated under 21 CFR 888.3030.

PEEK Implants: Smooth or threaded metallic bone fixation fastener, classified as Class II, product code HTY, regulated under 21 CFR 888.3040.

Instruments: Orthopedic Manual Surgical Instruments, classified as Class I, product code LXH, regulated under 21 CFR 888.4540. The reusable instruments, although may individually be Class I devices, are only intended for use with the RIGIDFIX CURVE Cross Pin System implants, thus taking on the classification of the parent device (in this case, Class II).

FDA PRODUCT CODE: COMMON CLASSIFICATION NAME:

HTY, MAI Pin, Fixation, Smooth (HTY); Fastener, Fixation, Biodegradable, Soft tissue (MAI)

RIGIDFIX® CURVE Cross Pin System PRODUCT: SUBMISSION DATE: January 14, 2013 SUBMISSION TYPE: TRADITIONAL ___

K130105 (1/2)

MAY 1 7 2013

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	never stop moving•

RIGIDFIX® CURVE Cross Pin System PRODUCT: SUBMISSION DATE: January 14, 2013 SUBMISSION TYPE: TRADITIONAL ... ... .......

K130105 (2/2)

ATTACHMENT 1 510(k) SUMMARY

DEVICE DESCRIPTION

INDICATIONS FOR USE

The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.

TECHNOLOGICAL CHARACTERISTICS

The proposed RIGIDFIX CURVE ST ACL PLA Cross Pin System implant is identical in material and design to the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant which has previously received 510(k) clearance (K974341, K090669, K091041).

The proposed RIGIDFIX CURVE ST ACL PEEK Cross Pin System implant is manufactured out of PEEK (polyetheretherketone), a non-absorbable radiolucent high strength thermoplastic material. The same PEEK material is used in manufacturing the predicate DePuy Mitek Gryphon PEEK Anchor (K 103712). Additionally, the RIGIDIFX CURVE ST ACL PEEK Cross Pin System implant has the same dimensional specification as the predicate RIGIDFIX Femoral 3.3mm ST Cross Pin Kit implant (K974341, K090669. K091041).

The proposed disposable (sleeves, trocar, bone gauge pin, and reusable (guide frame, guide block, arc attachment and femoral rods) instruments for use with the RIGIDFIX CURVE Cross Pin System are similar to those currently offered for use with the predicate RIGIDFIX System (K974341, K090669. K091041). The proposed and predicate disposable instruments are made of similar materials: stainless steel and radel. The proposed disposable instruments have been redesigned to allow the capability of being fully adjustable for desired angle of femoral cross pin implantation. The predicate RIGIDFIX System only allows for the insertion of cross pins perpendicular to the graft (termed 0 degrees).

SAFETY AND PERFORMANCE

NONCLINICAL TESTING

Product Design Verification activities such as In-Vitro Break Strength Testing and Real-Time Break Strength Testing were performed on the implants. Results of performance and safety testing have demonstrated that the proposed devices are substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed RIGIDFIX CURVE Cross Pin System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: May 17, 2013

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

Depuy Mitek, a Johnson & Johnson Company % Ms. Julie Vafides Regulatory Specialist II 325 Paramount Drive Raynham, Massachusetts 02767

Re: K130105

Trade/Device Name: RIGIDFIX® CURVE ST ACL PEEK Cross Pin System RIGIDFIX® CURVE ST ACL PLA Cross Pin System

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and

accessories

Regulatory Class: Class II Product Code: MAI, HTY Dated: April 12, 2013 Received: April 15, 2013

Dear Ms. Vafides:

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

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Page 2 - Ms. Julie Vafides

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 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/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 vours.

Mark Nightell erson -S

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

Enclosure

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DePuy
never stop moving"
Mitek, Inc.
A Johnson & Johnson company

RIGIDFIX® CURVE Cross Pin System PRODUCT: . SUBMISSION DATE: January 14, 2013 SUBMISSION TYPE: IRADITIONAT ----

ATTACHMENT 2

INDICATIONS FOR USE

510(k) Number (if known): K130105

Device Names: RIGIDFIX® CURVE ST ACL PEEK Cross Pin System RIGIDFIX® CURVE ST ACL PLA Cross Pin System

Indications for Use: The DePuy Mitek RIGIDFIX® CURVE Cross Pin System is indicated for femoral fixation of autograft or allograft anterior cruciate ligament (ACL) soft tissue grafts.

Prescription Use V Over-The-Counter Use AND/OR (Part 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 (ODE) Page I of

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.