The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

Device Description

The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Genesys Matryx™" bioabsorbable interference screw. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo performance criteria through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, specific study design, sample sizes, expert ground truth, MRMC studies, and standalone performance might not be fully available or directly applicable in the context of this 510(k) summary.

However, I can extract the relevant information from the provided text to address your points as much as possible, interpreting "acceptance criteria" as the basis for substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as legally marketed predicate devices. The "reported device performance" is then characterized through non-clinical testing to support this substantial equivalence.

Aspect of Equivalence	Acceptance Criteria (Demonstrated through comparison to predicates)	Reported Device Performance (as characterized by non-clinical testing)
Intended Use	"for attaching soft tissue to bone in orthopedic surgical procedures" and "interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate." Must be consistent with predicate devices.	The Genesys Matryx™ serves this intended use.
Design Characterization	Threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP).	The device is described as a "threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP)."
Material Characterization	Composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP). Similar materials to predicate devices.	The device is composed of "ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and beta-tricalcium phosphate (ß-TCP)."
Mechanical Performance	Maintains accurate position of a tendon/ligament graft, preserves high initial mechanical strength and stiffness, allows secure fixation. Must be comparable to predicate devices to allow "appropriate immobilization/controlled mobilization until clinical determination of healing." Resorption profile consistent with bioabsorbability.	"maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing." Non-clinical tests included insertion, pullout, and cyclic (reliability) testing.
Biological Performance (Resorption)	Complete resorption within several years, depending on patient variables. Similar resorption profile to predicate devices.	"Resorption also depends on patient variables. The Genesys Matryx completes resorption within several years." In vitro degradation testing was performed.
Safety and Biocompatibility	Sterile, non-collagenous. Must meet safety standards similar to predicate devices.	"The Genesys Matryx is sterile and non-collagenous." In vivo animal testing and bioburden testing were performed.
Other Performance Characteristics	Demonstrated stability during transport and shelf life.	Shelf life and transportation and distribution testing were performed.
Substantial Equivalence	Demonstrated equivalence in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the listed predicate devices: Linvatec Biomaterials Ltd Osteo ACL Screw (K032894), Linvatec Biomaterials Matryx Interference Screw (K052080), Depuy Metik MILAGRO Interference Screw (K060830), and Biocomposites Ltd. Bilok Screw (K071091).	The submission claims the Genesys Matryx is "substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics" to the listed predicates based on the non-clinical testing performed.

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

The document explicitly states: "Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing."

Test Set Sample Size: The document does not specify exact sample sizes for each of these non-clinical tests. For non-clinical tests, sample sizes are typically determined based on statistical justification for demonstrating material properties and mechanical performance, rather than patient cohorts.
Data Provenance: The testing is described as "non-clinical," which implies it was conducted under controlled laboratory conditions or using animal models for in vivo studies. There is no mention of human clinical data or patient-derived data in this 510(k) summary. Given the non-clinical nature, country of origin specifics are not provided, but these tests would typically be performed in a controlled research facility. The data is entirely retrospective in the sense that it's generated for submission, not from ongoing patient care.

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

Since this is a non-clinical 510(k) submission, there is no mention of "experts used to establish ground truth" in the context of clinical interpretation, especially not like radiologists for image analysis. The "ground truth" for the non-clinical tests (e.g., pullout strength, degradation rate) would be the objective measurements and analysis performed by engineers, material scientists, and laboratory personnel following established protocols and standards. Their qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies with human readers/assessors. As this is a non-clinical testing summary for a 510(k) submission, such methods are not relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study is a type of clinical study involving human readers interpreting cases, often in the context of diagnostic imaging. This 510(k) summary only mentions non-clinical testing.

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

Yes, in essence. The "Genesys Matryx™" is a physical medical device (an interference screw), not a software algorithm. Therefore, its performance is inherently "standalone" in function, meaning it acts independently once implanted according to its mechanical and absorbable properties. The non-clinical tests assess the device's inherent performance characteristics without human interpretation as part of its function.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on objective, quantifiable measurements from the specified non-clinical tests:

In vivo animal testing: Physiological responses, integration, or degradation in a living system. Ground truth would be derived from histological analysis, imaging, and necropsy findings.
In vitro degradation: Chemical and physical analysis (e.g., mass loss, mechanical property changes) over time in a simulated environment.
Shelf life, transportation and distribution: Stability and integrity of the device under stress conditions, assessed against pre-defined specifications.
Verification by analysis: Engineering calculations and simulations.
Insertion, pullout, cyclic (reliability) testing: Direct mechanical measurements (e.g., force, displacement, cycles to failure) using standardized test methods.
Bioburden testing: Microbiological analysis to quantify microbial contamination levels.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized swoosh shape on the left, followed by the text "CONMED" in bold, sans-serif font. Below the text is the word "LINVATEC" in a smaller font. The address "11311 Concept Boulevard, Largo, FL 33773" is printed below the logo.

711 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.limatec.com

@EC 2 | 2010

5. 510(k) Summary

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number_

Date Prepared: December 2, 2010

A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

Regulatory Contact: Ashlea Bowen Regulatory Affairs Specialist (727) 399-5564 Telephone (727) 399-5264 Fax

C. Device Name

Trade Name:	Genesys Matryx™
Common Name:	Bioabsorbable Interference Screw
Classification Name:	Biodegradable soft tissues fixation fastener
Proposed Class/Device:	Class II
Product Code:	HWC
Regulation:	21 CFR Part 888.3040

D. Predicate/Legally Marketed Devices

Device Name:	Osteo ACL Screw
Company Name:	Linvatec Biomaterials Ltd.
510(k) #:	K032894
Device Name:	Matryx Interference Screw
Company Name:	Linvatec Biomaterials Ltd.
510(k) #:	K052080
Device Name:	MILAGRO Interference Screw
Company Name:	Depuy Mitek
510(k) #:	K060830

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Image /page/1/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized "C" shape on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "LINVATEC" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.

11311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.linvatec.com

Device Name: Company Name: 510(k) #:

Bilok Screw Biocomposites Ltd K071091

E. Device Description

F. Intended Use / Indications

G. Substantial Equivalence

The Genesys Matryx substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the Linvatec Biomaterials Ltd Osteo ACL Screw (K032894), the Linvatec Biomaterials Matryx Interference Screw (K052080), the Depuy Metik MILAGRO Interference Screw (K060830), and the Biocomposites Ltd. Bilok Screw (K071091).

H. Non-Clinical Testing

Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing.

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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 stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

ConMed Linvatec % Ms. Ashlea Brown Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

Re: K102410

DEC 2 1 2010

Trade/Device Name: Genesys MatryxTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 1, 2010 Received: December 2, 2010

Dear Ms. Brown:

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.

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 - Ms. Ashlea Brown

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/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,

Acing B. n
fr.

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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Image /page/4/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized white crescent shape on the left, followed by the word "CONMED" in bold, black capital letters. Below "CONMED" is the word "LINVATEC" in smaller, black capital letters. The logo appears to be for a medical technology company.

1311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.lluviaetc.com

4. Indications for Use

DEC 2 1 2010

1/02410 (pg 1/1) 510(k) Number (if known):

Device Name: Genesys Matryx ™

Indications for Use:

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 CDRN, Office of Device Evaluation (ODE)	for M. Mckerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K102440

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.