(84 days)
Not Found
No
The summary describes a bioabsorbable implant and its delivery system, focusing on material properties and biological function. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the management and protection of tendon or extra-articular ligament injuries, which points to a therapeutic use.
No
The device is an implant designed for the management and protection of tendon or extra-articular ligament injuries by providing a layer of collagen, not for diagnosing conditions.
No
The device description clearly states it is a bioabsorbable implant device made of collagen, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The REGENETEN Bioinductive Implant is a physical implant designed to be placed within the body to manage and protect tendon or ligament injuries. It is not used to analyze samples taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or laboratory procedures typically associated with IVDs.
This device is an implantable medical device used for surgical repair and support of tissues.
N/A
Intended Use / Indications for Use
The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.
The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.
Product codes
OWY, ORQ
Device Description
The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendon or extra-articular ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Smith and Nephew conducted an animal study with multiple timepoints evaluating the REGENETEN Bioinductive Implant in an in vivo ovine bilateral model with a primary histology endpoint to demonstrate ligament-like tissue formation post-capsulotomy. A direct comparative analysis between sutured repair (control group) and sutured repair with Bioinductive Implant (treatment group) evaluated healing progression, formation of neo-tissue, and resemblance to native tissue. Results show the Bioinductive Implant results in increased ligament thickness and that the Bioinductive Implant can be safely implanted for ligament repair without raising any new issues of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2024
Smith & Nephew Inc., Endoscopy Div. Lacev Klungseth Pr. Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K242631
Trade/Device Name: REGENETEN™ Bioinductive Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWY, ORQ Dated: August 28, 2024 Received: September 3, 2024
Dear Lacey Klungseth:
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.
1
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" (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 QS 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 Rule"). 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.
For comprehensive regulatory information about medical devices and radiation-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-regulatory
2
assistance/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,
CHRISTOPHER FERREIRA -S
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) K242631
Device Name REGENETEN™ Bioinductive Implant
Indications for Use (Describe)
The REGENETEN Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.
The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Smith & Nephew, Inc. Endoscopy 150 Minuteman Road Andover, MA 01810 Massachusetts, USA
T: +1 978 749 1000 T: +1 800 343 8386 (USA toll free) www.smith-nephew.com
Smith Nephew
Attachment 15:
510(k) Summary According to 21 CFR 807.92
| Date Prepared: | November 8, 2024 | |
|---|---|---|
| Submitter Name & Address: | Smith and Nephew, Inc. | |
| Endoscopy | ||
| 150 Minuteman Road | ||
| Andover, MA 01810 | ||
| FDA Establishment Owner/Operator Number: | 1020279 | |
| FDA Establishment Registration Number: | 3003604053 | |
| Submitter / Primary Contact: | Lacey Klungseth | |
| Pr. Regulatory Affairs Specialist | ||
| (612) 443-2734 | ||
| Lacey.Klungseth@Smith-Nephwe.com | ||
| Alternate Contact: | Jenna Horsley | |
| Regulatory Affairs Director | ||
| (617) 218-7921 | ||
| Jenna.Horsley@smith-nephew.com | ||
| Device Trade / Proprietary Name: | REGENETEN™ Bioinductive Implant | |
| Device Common Name: | Surgical mesh | |
| Device Classification Name: | Mesh, Surgical, Collagen, Orthopaedics | |
| Regulation Medical Specialty: | Office of General & Plastic Surgery | |
| Review Panel(s): | Office of General & Plastic Surgery | |
| Product Code(s): | OWY (Bioinductive Implant), | |
| ORQ (Bioinductive Implant Delivery Instrument) | ||
| Regulation Numbers: | 21 CFR 878.3300 | |
| Submission Type: | Traditional 510(k) | |
| Device Class: | Class II | |
| Device Predicate: | REGENETEN™ Bioinductive Implant (K222501) |
5
Smith & Nephew, Inc. Endoscopy 150 Minuteman Road Andover MA 018 Massachusetts, US
T: +1 978 749 1000 +1 800 343 8386 (USA toll free) h-nenhew com
Image /page/5/Picture/2 description: The image shows the Smith+Nephew logo in orange. Below the logo is the text "K242631" in black. The logo is a recognizable brand mark.
Device Description:
The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.
Proposed Intended Use
The REGENETEN™ Bioinductive* Implant is a medical device intended for the management and protection of soft tissue injuries, including tendon and extra-articular liqament.
Proposed Indications for Use
The REGENETEN™ Bioinductive Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue.
- Bioinductivity has been demonstrated for tendon only.
The REGENETEN™ Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN™ Bioinductive Implant.
Summary of Technological Characteristics Compared to Predicate Device:
The subject device (REGENETEN Bioinductive Implant) and the predicate device (REGENETEN Bioinductive Implant, K222501), are identical devices, having the same physical performance characteristics, packaging, and material composition. Past safety, bench testing, and animal study of the predicate device are directly applicable to the subject device. Previous verification testing completed is directly applicable to the subject device, including staple pull-out testing, hydrothermal transition temperature, endotoxin testing, and mechanical integrity.
The subject device has identical technological characteristics as the predicate device with the addition of the expanded indication. The expanded indications for use did not require any change in the device design, material composition, and packaging and this technological difference is supported by, valid, reproducible performance testing.
Biocompatibility:
The subject device (REGENETEN Bioinductive Implant) and the predicate device (REGENETEN Bioinductive Implant, K222501) are physically identical devices; therefore, additional biocompatibility testing is not required to support this submission.
Performance Data (Bench Testing):
The Regeneten Bioinductive Implant is identical to the predicate device (REGENETEN Bioinductive Implant, K222501) and performance specifications are identical. Past safety, verification, and mechanical characterization tests of the predicate device are directly applicable to the subject device, including staple pull-out testing, hydrothermal transition temperature, endotoxin testing, and mechanical integrity.
6
Smith & Nephew, Inc. Endoscopy 150 Minuteman Road Andover. MA 0181 Massachusetts, USA
T: +1 978 749 1000 +1 800 343 8386 (USA toll free) w.smith-nenhew.com
Image /page/6/Picture/2 description: The image contains the Smith & Nephew logo in orange. Below the logo is the text "K242631" in black. The logo is a stylized version of the company name, with a plus sign incorporated into the "N" of Nephew.
Performance Data (Animal Testing):
Smith and Nephew conducted an animal study with multiple timepoints evaluating the REGENETEN Bioinductive Implant in an in vivo ovine bilateral model with a primary histology endpoint to demonstrate ligament-like tissue formation post-capsulotomy.
A direct comparative analysis between sutured repair (control group) and sutured repair with Bioinductive Implant (treatment group) evaluated healing progression, formation of neo-tissue, and resemblance to native tissue. Results show the Bioinductive Implant results in increased ligament thickness and that the Bioinductive Implant can be safely implanted for ligament repair without raising any new issues of safety and effectiveness.
Bioinductivity has been demonstrated for tendon only.
Compliance to Standards:
This submission does not claim compliance to any new FDA recognized consensus standards.
Substantial Equivalence and Conclusion:
No design modifications were completed regarding the expanded indications for use and the subject device (REGENETEN Bioinductive Implant) is identical to the predicate device (REGENETEN Bioinductive Implant, K222501) in terms of material composition, design, packaging, sterilization, and biocompatibility. The only difference is the addition of ligament tissue to the indications for use.
Expansion of indications for use to include management and protection of extra-articular ligament injuries does not impact the intended surgical purpose of the device, nor does it affect the safety and efficacy of the device relative to the predicate. Both the subject and predicate devices have the same intended surgical purpose.
This difference is substantiated by reviewing the results of the animal study presented in this 510(k). Based on the comparative analysis, the REGENETEN Bioinductive Implant has been shown to be substantially equivalent to its predicate, the REGENETEN Bioinductive Implant (K222501). They are the same device: the technological characteristics, packaging, and sterilization parameters are identical. Only the indications for use have changed.