(58 days)
Not Found
No
The summary describes a collagen implant for meniscus repair and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended for the reinforcement and repair of the medial meniscus, which aligns with the definition of a therapeutic device as it directly addresses a medical condition to restore function or improve health outcomes.
No
The RejuvaKnee is described as a device intended for surgical procedures to reinforce and repair the medial meniscus, acting as a resorbable scaffold. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of bovine collagen, intended for surgical procedures. There is no mention of software components.
Based on the provided information, the RejuvaKnee device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for surgical procedures to reinforce and repair the medial meniscus. This is a therapeutic and structural repair function performed in vivo (within the body).
- Device Description: The device is a collagen implant designed to be surgically placed within the body.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The RejuvaKnee does not perform any such function. It is a physical implant.
Therefore, the RejuvaKnee is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
OLC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial meniscus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
1
(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.
2
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
3
Indications for Use
510(k) Number (if known) K242302
Device Name
RejuvaKnee™ Collagen Meniscus Implant
Indications for Use (Describe)
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.
| 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 Road | ||
| Oakland, New Jersey 07436 | ||
| Telephone: | ||
| Fax: | (201) 405-1477 | |
| (201) 405-1355 | ||
| Contact Person: | Devin Dragon | |
| Sr. Regulatory Specialist | ||
| ddragon@regenity.com | ||
| Date Prepared: | September 30, 2024 | |
| 2. | Name of the Device | |
| Device Trade Name: | RejuvaKnee™ Collagen Meniscus Implant | |
| K242302 | ||
| Device Common Name(s): | Scaffold, Partial Medial Meniscal Defects Extending into | |
| the Red/White Zone, Resorbable Bovine Collagen | ||
| Device Classification Name: | Surgical Mesh | |
| 878.3300 | ||
| OLC | ||
| Class II | ||
| 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Predicate Device: | Collagen Meniscus Implant | |
| Stryker Endoscopy | ||
| (originally Ivy Sports Medicine, LLC) | ||
| K170364 |
4. Description of the Device
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.
5
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 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 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. | The Collagen Meniscus Implant (CMI) 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 | ||
| CMI must extend at least into the red/white | ||
| zone of the meniscus to provide sufficient | ||
| vascularization. | ||
| The CMI reinforces soft tissue and provides a | ||
| resorbable scaffold that is replaced by the | ||
| patient's own soft tissue. The CMI is not a | ||
| prosthetic device and is not intended to replace | ||
| normal body structure. | ||
| Chemical and Physical Properties | ||
| Material | ||
| Composition | 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 mm | |
| Large Medial - 9 mm | Small Medial – 7.5 mm | |
| Large Medial – 9 mm | ||
| XL Medial | ||
| Porosity - SEM of | ||
| the outer and | ||
| cross-section (not | ||
| regular testing) | Provides sufficient porosity to allow for cellular | |
| integration from host tissue |
5 micron | Provides sufficient porosity to allow for cellular
integration 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 Implant
From Stryker Endoscopy |
|---------------------------|------------------------------------------------------------|-------------------------------------------------------------------------|
| Thermal Stability
(°C) | $60 ± 3$ | $61±1$ |
| Biocompatibility | Meets ISO 10993 biocompatibility series of
testing | Biocompatible |
| Sterility | Sterile, SAL 10-6 using Gamma irradiation | Sterile, SAL 10-6 using Gamma irradiation |
| Pyrogenicity | Non-pyrogenic -