RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.

Device Description

The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.

RejuvaKnee is supplied sterile and is intended for single use.

AI/ML Overview

This is a 510(k) summary for the RejuvaKnee™ Collagen Meniscus Implant.
The device is a resorbable scaffold made of bovine Type I collagen intended for the reinforcement and repair of medial meniscal defects. It is compared to the Ivy Sports Medicine Collagen Meniscus Implant (K170364) as a predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison of features between the RejuvaKnee™ Collagen Meniscus Implant and its predicate. Acceptance criteria are implied by the reported values and the claim of substantial equivalence to the predicate.

Feature	Acceptance Criteria (Implied by Predicate & Device Performance)	RejuvaKnee™ Collagen Meniscus Implant Performance
Indications for Use	Substantially equivalent to predicate	Same as predicate
Material Composition	Type I bovine collagen	Primarily Type I bovine collagen
Material Origin	Bovine	Bovine
Tissue Source	Not explicitly defined as an acceptance criterion; comparison shown	Meniscus
Physical Form	Semi-lunar shape with triangular cross-section	Semi-lunar shape with a triangular cross-section
Product Sizes (cm)	Comparable to predicate	Small Medial - 7.5 mm; Large Medial - 9 mm
Porosity - SEM	Sufficient to allow for cellular integration from host tissue (>5 micron for RejuvaKnee)	Provides sufficient porosity to allow for cellular integration from host tissue (>5 micron)
pH	Comparable to predicate (predicate: 7.12)	6 - 9.5
Tensile Strength (kg/cm²)	Comparable to predicate (predicate: 62.5 kg/cm²)	≥ 150
Suturability (kg)	Comparable to predicate (predicate: 0.86 ±0.08 kg)	≥ 0.5
Thermal Stability (°C)	Comparable to predicate (predicate: 61±1 °C)	60 ± 3
Biocompatibility	Meets ISO 10993 series of testing	Meets ISO 10993 biocompatibility series of testing
Sterility	Sterile, SAL 10-6 using Gamma irradiation	Sterile, SAL 10-6 using Gamma irradiation
Pyrogenicity	Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device	Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device
Single Use/Reuse	Single use only	Single use only

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

Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Specific sample sizes for each test within the series are not provided but would be standard for such evaluations. Data provenance is not specified but is typically from laboratory testing in a controlled environment.
Bench Testing: Testing included dimensions, porosity, pH, tensile strength, suturability, pyrogenicity, and thermal stability. "Each lot of finished devices is tested for bacterial endotoxin for lot release." Specific sample sizes per test are not provided but are routine for product characterization. Data provenance is from laboratory testing.
Animal Testing: The performance was evaluated in goat and canine models. The exact number of animals is not specified. Data provenance is from animal studies.

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

This information is not applicable as the studies presented are non-clinical (bench and animal testing). There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies presented are non-clinical.

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

No MRMC comparative effectiveness study was mentioned or performed. The studies are non-clinical and focus on demonstrating substantial equivalence of the material and physical properties of the device.

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

This information is not applicable as the device is a physical medical implant, not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used:

Bench Testing: The "ground truth" is established by direct measurement against quantitative specifications and comparison to the predicate device's reported characteristics.
Biocompatibility Testing: The "ground truth" is adherence to the requirements of the ISO 10993-1 standard.
Animal Testing: The "ground truth" is the observed biological response in the animal models, including safety, biocompatibility, tissue repair/remodeling, and biomechanical function, compared against expected outcomes and published performance of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable as the studies involve physical device testing, not machine learning or algorithm training.

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

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 2, 2024

Collagen Matrix, Inc. Devin Dragon Sr. Regulatory Specialist 15 Thornton Road Oakland, New Jersey 07436

Re: K242302

Trade/Device Name: RejuvaKnee™ Collagen Meniscus Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OLC Dated: August 2, 2024 Received: August 5, 2024

Dear Devin Dragon:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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evices and radiation-emitting products, including

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thomas Mcnamara -S

For: Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242302

Device Name

RejuvaKnee™ Collagen Meniscus Implant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1.	Applicant Information
	Applicant Name:Address:	Collagen Matrix, Inc.15 Thornton RoadOakland, New Jersey 07436
	Telephone:Fax:	(201) 405-1477(201) 405-1355
	Contact Person:	Devin DragonSr. Regulatory Specialistddragon@regenity.com
	Date Prepared:	September 30, 2024
2.	Name of the Device
	Device Trade Name:	RejuvaKnee™ Collagen Meniscus ImplantK242302
	Device Common Name(s):	Scaffold, Partial Medial Meniscal Defects Extending intothe Red/White Zone, Resorbable Bovine Collagen
	Device Classification Name:	Surgical Mesh878.3300OLCClass II
3.	Legally Marketed Devices to Which Substantial Equivalence is Claimed
	Predicate Device:	Collagen Meniscus ImplantStryker Endoscopy(originally Ivy Sports Medicine, LLC)K170364

4. Description of the Device

RejuvaKnee is supplied sterile and is intended for single use.

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5. Intended Use

RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

RejuvaKnee reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.

Summary/Comparison of Technical Characteristics 6.

The subject device and predicate device have indications for use. The subject device has substantially equivalent technological characteristics as the predicate device. Differences in tissue source are minimized after processing and purification.

Feature	RejuvaKnee™ Collagen Meniscus Implant	Ivy Sports Medicine Collagen Meniscus Implant
	(This submission)	From Stryker Endoscopy
Indications for Use	RejuvaKnee is intended for use in surgicalprocedures for the reinforcement and repair ofsoft tissue injuries of the medial meniscus. Inrepairing and reinforcing medial meniscaldefects, the patient must have an intact meniscalrim and anterior and posterior horns forattachment of the mesh. In addition, thesurgically prepared site for RejuvaKnee mustextend at least into the red/white zone of themeniscus to provide sufficient vascularization.RejuvaKnee reinforces soft tissue and provides aresorbable scaffold that is replaced by thepatient's own soft tissue. The RejuvaKnee is not aprosthetic device and is not intended to replacenormal body structure.	The Collagen Meniscus Implant (CMI) is intendedfor use in surgical procedures for thereinforcement and repair of soft tissue injuriesof the medial meniscus. In repairing andreinforcing medial meniscal defects, the patientmust have an intact meniscal rim and anteriorand posterior horns for attachment of the mesh.In addition, the surgically prepared site for theCMI must extend at least into the red/whitezone of the meniscus to provide sufficientvascularization.The CMI reinforces soft tissue and provides aresorbable scaffold that is replaced by thepatient's own soft tissue. The CMI is not aprosthetic device and is not intended to replacenormal body structure.
Chemical and Physical Properties
MaterialComposition	Primarily Type I bovine collagen	Type I bovine collagen
Material Origin	Bovine	Bovine
Tissue Source	Meniscus	Deep flexor Achilles tendon
Physical Form	Semi-lunar shape with a triangular cross-section	Semi-lunar shape with a triangular cross-section
Product Sizes (cm)	Small Medial - 7.5 mmLarge Medial - 9 mm	Small Medial – 7.5 mmLarge Medial – 9 mmXL Medial
Porosity - SEM ofthe outer andcross-section (notregular testing)	Provides sufficient porosity to allow for cellularintegration from host tissue>5 micron	Provides sufficient porosity to allow for cellularintegration from host tissue
pH	6 - 9.5	7.12
Tensile Strength(kg/cm²)	≥ 150	62.5
Suturability (kg)	≥ 0.5	0.86 ±0.08

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Feature	RejuvaKnee™ Collagen Meniscus Implant(This submission)	Ivy Sports Medicine Collagen Meniscus ImplantFrom Stryker Endoscopy
Thermal Stability(°C)	$60 ± 3$	$61±1$
Biocompatibility	Meets ISO 10993 biocompatibility series oftesting	Biocompatible
Sterility	Sterile, SAL 10-6 using Gamma irradiation	Sterile, SAL 10-6 using Gamma irradiation
Pyrogenicity	Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device	Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device
Single Use/ Reuse	Single use only	Single use only

7. Performance Data

In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate device. The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility testing was conducted in accordance with the testing matrix of ISO 10993-1.

Bench Testing

Collagen characterization testing and product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate. Testing included dimensions, porosity, pH, tensile strength, suturability, pyrogenicity and thermal stability. Each lot of finished devices is tested for bacterial endotoxin for lot release.

Animal Testing

The performance of the device in goat and canine models confirmed that RejuvaKnee is safe, biocompatible and associated with meniscus defect tissue repair and remodeling, and provides the necessary medial condyle support and biomechanics to prevent secondary joint changes resulting from an untreated partial meniscectomy. The performance in the canine model was compared to the published performance of the predicate device and confirmed equivalent performance.

Clinical Studies

Clinical performance of the RejuvaKnee™ Collagen Meniscus Implant subject device was evaluated in a simulated clinical setting to demonstrate that the RejuvaKnee maybe successfully implanted equivalent to the predicate device. The subject device is the same intended use, design, and bovine-derived collagen safety profile as the predicate device. Based on the equivalent material and performance specifications, and equivalent principle of operation to the predicate device, clinical studies of the subject device are not needed to support substantial equivalence.

Conclusions Drawn from Non-clinical Studies 8.

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate device.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.