BioBrace® Reinforced Implant

K241906 · Conmed Corporation · OWW · Jul 29, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K241906
• Device Name: BioBrace® Reinforced Implant
• Applicant: Conmed Corporation
• Product Code: OWW · General, Plastic Surgery
• Decision Date: Jul 29, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioBrace® Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

Device Story

Bioresorbable, reinforced surgical implant; composed of highly-porous bovine type-1 collagen sponge reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. Used in surgical settings for soft tissue reinforcement during tendon repair. Implant provides structural scaffold; does not replace native tissue or provide primary mechanical strength, which remains dependent on sutures/anchors. Single-use; supplied sterile. Surgeon-operated during orthopedic/general procedures. Benefits include soft tissue reinforcement to support healing.

Clinical Evidence

Bench testing only. Performance data includes transportation qualification, sterilization validation, user validation, packaging/labeling validation, and mechanical performance testing.

Technological Characteristics

Bioresorbable scaffold; 80% porous (median pore 19 μm); 3 mm thick. Materials: bovine tendon type-1 collagen, PLLA multifilament yarn, PEG 400. PLLA properties: melting temp 178–184°C, inherent viscosity 1.20–1.70 dL/g. Biocompatibility per ISO 10993-1. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for reinforcement of soft tissue in general surgical procedures and soft tissues repaired by suture/anchors during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps). Contraindicated for ligament repair/reconstruction and patients with hypersensitivity to bovine-derived materials.

Regulatory Classification

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.

Predicate Devices

• The BioBrace™ Implant (K203267)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 29, 2024

CONMED Corporation
Mirela Gjini
Regulatory Affairs Associate
525 French Rd
Utica, New York 13502

Re: K241906
Trade/Device Name: BioBrace® Reinforced Implant
Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical Mesh
Regulatory Class: Class II
Product Code: OWW, OWY
Dated: June 28, 2024
Received: July 1, 2024

Dear Mirela Gjini:

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" (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).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K241906 - Mirela Gjini
Page 2

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 (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-reporting-combination-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.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Christopher Ferreira -S

for

Jesse Muir, Ph.D.

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

{2}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)

K241906

Device Name

BioBrace® Reinforced Implant

Indications for Use (Describe)

The BioBrace® Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

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

☑ 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
[e-mail]

"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."

{3}

K241906
Page 1 of 3

510(k) SUMMARY
BioBrace® Reinforced Implant

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, CONMED Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K241906.

I. SUBMITTER
Manufacturer:
CONMED Corporation
525 French Road
Utica, NY 13502

Official Contact Person:
Mirela Gjini
525 French Road
Utica, NY 13502
(O) 727-392-6464

Date Prepared: June 28, 2024

II. DEVICE NAME
Device Name: BioBrace® Reinforced Implant
Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulatory Class: Class II, per 21 CFR Part 878.3300
Product Codes: OWW, OWY

III. PREDICATE DEVICE
Device Name: The BioBrace™ Implant
Company Name: CONMED Corporation
510(k) #: K203267

IV. DEVICE DESCRIPTION
The device is a bioresorbable, reinforced Implant composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. The BioBrace® Implant is 80% porous with a median pore diameter of 19 μm. BioBrace® Implants are approximately 3 mm thick, provided in rectangular sizes of 23 x 25 mm, 35 x 25 mm, and 40 x 60mm. The BioBrace® Implant is single-use and supplied sterile.

V. INTENDED USE/ INDICATIONS FOR USE
The BioBrace® Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or

{4}

quadriceps tendons. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| | Proposed Device | Predicate Device |
| --- | --- | --- |
| Manufacturer Device Name 510k Number | CONMED Corporation BioBrace® Reinforced Implant K241906 | Biorez, Inc The BioBrace™ Implant K203267 |
| Intended Use/Indications for Use | The BioBrace Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair. | The BioBrace Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair. |
| Contraindications | The BioBrace alone is not indicated for ligament repair or reconstruction. The BioBrace is not indicated for use in patients with known history of hypersensitivity to bovine-derived materials. | The BioBrace alone is not indicated for ligament repair or reconstruction. The BioBrace is not indicated for use in patients with known history of hypersensitivity to bovine-derived materials. |
| How Supplied | Sterile | |
| Single Use/Reusable | Single-Use Only | |
| Sterilization | Ethylene Oxide Sterilization achieving a SAL (10-6) | |
| Shelf-Life | 6-months | 2-years based on real-time data |
| Biocompatibility | In accordance with ISO 10993-1 | |

K241906
Page 2 of 3

{5}

| Packaging | Temperature label, retention box kit, pouch, envelope shelf box, packaging insert card, eIFU insert, patient implant card. | Temperature label, retention box kit, pouch, envelope shelf box, packaging insert card. |
| --- | --- | --- |
| Base Material | 75 denier multi filament PLLA yarn, collagen, PEG 400 | |
| Physical form / Porosity | Porous mesh / scaffold - 80% | |
| PLLA Properties | Peak Melting Temperature, PLLA ©: 178 – 184°C
Inherent Viscosity, PLLA (dL/g):1.20 – 1.70 dL/g | |
| Sizes | 23X25mm
35X25mm
40X60mm | 23X30mm; 5X250mm |
| Bioresorbable | Yes | |

VII. PERFORMANCE DATA

Testing and analysis has been completed to demonstrate that BioBrace® Reinforced Implant performs as intended and is substantially equivalent to the predicate device.

- Transportation Qualification
- Sterilization
- User Validation
- Packaging and Labeling User Validation
- Mechanical Performance

VIII. CONCLUSION

The proposed and the predicate devices are substantially equivalent in design and technological characteristics. Difference in dimension, labeling, and the addition of a sterilization site do not present any new issues of safety and efficacy based on validation testing and transportation evaluations. The BioBrace Reinforced Implant is substantially equivalent to the predicate device, The BioBrace™ Implant (K203267).

K241906
Page 3 of 3