Coaptium Connect with Tissium Light

K251957 · Tissium SA · SFD · Sep 8, 2025 · Neurology

Device Facts

• Record ID: K251957
• Device Name: Coaptium Connect with Tissium Light
• Applicant: Tissium SA
• Product Code: SFD · Neurology
• Decision Date: Sep 8, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5270
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

COAPTIUM® Connect with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

Device Story

Bioabsorbable coaptation system for sutureless peripheral nerve repair; consists of implantable 3D coaptation chamber and photoactive COAPTIUM polymer; used to bridge nerve segments distal and proximal to injury. System includes single-use syringe, silicone applicator, syringe tip, and TISSIUM Light Cover. TISSIUM LIGHT (reusable) provides on-demand polymerization of photoactive polymer. Used in clinical settings by surgeons; polymer applied to chamber and nerve segments; light cover facilitates polymerization. Provides protective interface for axonal growth; degrades via hydrolysis. Benefits include sutureless repair and conduit for nerve healing.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility per ISO 10993-1:2018, shelf-life validation, and sterilization validation. All testing met predetermined acceptance criteria.

Technological Characteristics

Bioabsorbable 3D coaptation chamber; photoactive polymer; silicone applicator; TISSIUM Light Cover. Transparent, flexible sleeve form factor. Energy source: TISSIUM LIGHT (light-based polymerization). Sterilization: Sterile. Biocompatibility: ISO 10993-1:2018 compliant.

Indications for Use

Indicated for sutureless repair of peripheral nerve injuries not in continuity with gap closure ≤ 1 cm (achievable via extremity flexion).

Regulatory Classification

Identification

COAPTIUM CONNECT with TISSIUM LIGHT is an in situ polymerizing peripheral nerve repair device indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity. It is composed of, in whole or in part, starting materials that polymerize when delivered to a peripheral nerve injury.

Special Controls

In combination with the general controls of the FD&C Act, the in situ polymerizing peripheral nerve repair device is subject to the following special controls: (1) In vivo performance testing in a clinically relevant model and defect size must demonstrate that the device performs as intended for the repair of peripheral nerve injuries and assess device preparation and deliverability, tissue reactions to the device or degradation products, device migration, and all adverse effects. (2) A characterization of the following chemical characteristics of the polymerization process must describe how the in situ application of the precursor materials will result in a consistent final device. All physico-chemically relevant changes to parts (iii)-(vi) below are determined to significantly affect the safety or effectiveness of the device (21 CFR 807.81(a)(3)(i)) and must be described in a premarket notification: (i) The technical specifications of the precursor materials and polymerization initiators including the chemical formulation, chemical analysis, appearance, and physical characteristics; (ii) The delivery mechanism of the precursor materials to the site of application; (iii) The polymerization mechanism and polymer structure; (iv) The intermediates or side products produced; (v) The degradation pathway and degradants; and (vi) The contribution of any initiators or quenchers to the polymer, intermediates or side products, and degradants. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Characterization of the polymerized final device must be performed. Physico-chemically relevant changes to the characteristics below are determined to significantly affect the safety or effectiveness of the device (21 CFR 807.81(a)(3)(i)) and must be described in a premarket notification: (A) The polymerization mechanism and polymer structure; (B) The intermediates or side products produced; (C) The degradation pathway and degradants; and (D) The contribution of any initiators or quenchers to the polymer, intermediates or side products, and degradants. (ii) Mechanical integrity testing, including elastic modulus, compression, swelling, and rebound testing, must be performed. (iii) Physico-chemical testing of the polymerized device including dimensions, chemical analysis, and reaction temperature must be performed. (iv) Device deliverability testing with any applicator(s), initiator(s), or delivery system(s) must be performed. (4) Human factors/usability testing must demonstrate that the intended user(s) in the intended use environment can correctly and safely use the device following the instructions for use. (5) The tissue-contacting components of the precursor materials, intermediate or side products, degradants, and final polymerized device must be demonstrated to be biocompatible. (6) Performance data must demonstrate the sterility of all tissue-contacting components of the device and any delivery systems. (7) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (8) Labeling must include: (i) Instructions on proper device preparation and implantation; (ii) Description of the device technical parameters and all components; and (iii) A shelf life.

Predicate Devices

• COAPTIUM® Connect with TISSIUM® LIGHT (DEN240066)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

September 8, 2025

TISSIUM SA
Bahija Ikched
Senior Regulatory Project Manager
74 rue du Faubourg Saint Antoine
Paris, 75012
France

Re: K251957
Trade/Device Name: Coaptium Connect with Tissium Light
Regulation Number: 21 CFR 882.5270
Regulation Name: In Situ Polymerizing Peripheral Nerve Repair Device
Regulatory Class: Class II
Product Code: SFD
Dated: June 25, 2025
Received: August 19, 2025

Dear Bahija Ikched:

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

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K251957 - Bahija Ikched
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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.

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-devices/device-advice-comprehensive-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-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).

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K251957 - Bahija Ikched
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Sincerely,

Adam D. Pierce -S
Digitally signed by
Adam D. Pierce -S
Date: 2025.09.08
08:29:59 -04'00'

Adam D. Pierce, Ph.D.
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
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PSC Publishing Services [phone]
EF

| 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. |
| --- | --- |
| 510(k) Number (if known) K251957 | |
| Device Name COAPTIUM® CONNECT with TISSIUM® LIGHT | |
| Indications for Use (Describe) COAPTIUM® CONNECT with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity. | |
| 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." | |

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510(k) SUMMARY

Submitter Information:
TISSIUM S.A.
74 rue du Faubourg Saint Antoine
75012 Paris, France

Contact Person:
Bahija IKCHED
Senior Regulatory Project Manager
[phone]

Date the Summary was prepared: August 29, 2025

Name of the device:
Trade Name: COAPTIUM® Connect with TISSIUM® LIGHT
Common Name: COAPTIUM® Connect
Classification: 21 CFR 882.5270 In situ polymerizing peripheral nerve repair device
Product Code: SFD
Model numbers: NCOCO1575: COAPTIUM® Connect 1.5mm (D) x 7.5mm (L)
NCOCO2075: COAPTIUM® Connect 2.0mm (D) x 7.5mm (L)
NCOCO3075: COAPTIUM® Connect 3.0mm (D) x 7.5mm (L)
NCOCO4075: COAPTIUM® Connect 4.0mm (D) x 7.5mm (L)
NCOCO5075: COAPTIUM® Connect 5.0mm (D) x 7.5mm (L)
NCOCO6075: COAPTIUM® Connect 6.0mm (D) x 7.5mm (L)
NCOCO1510: COAPTIUM® Connect 1.5mm (D) x 10mm (L)
NCOCO2010: COAPTIUM® Connect 2.0mm (D) x 10mm (L)
NCOCO3010: COAPTIUM® Connect 3.0mm (D) x 10mm (L)
NCOCO4010: COAPTIUM® Connect 4.0mm (D) x 10mm (L)
NCOCO5010: COAPTIUM® Connect 5.0mm (D) x 10mm (L)
NCOCO6010: COAPTIUM® Connect 6.0mm (D) x 10mm (L)
NCOCO3015: COAPTIUM® Connect 3.0mm (D) x 15mm (L)
NCOCO4015: COAPTIUM® Connect 4.0mm (D) x 15mm (L)
NCOCO5015: COAPTIUM® Connect 5.0mm (D) x 15mm (L)
NCOCO6015: COAPTIUM® Connect 6.0mm (D) x 15mm (L)

Predicate Device: COAPTIUM® Connect with TISSIUM® LIGHT (DEN240066 granted June 17, 2025)

Device Description:
COAPTIUM® Connect is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer, which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury.
The system includes implantable components, the coaptation chamber and the COAPTIUM® polymer, and three sterile disposable accessories: a silicone applicator (base and cap), a syringe tip, and a TISSIUM® Light Cover.
The coaptation chamber and the COAPTIUM® polymer are designed to serve as a protective interface between the peripheral nerve and the surrounding tissues over time and create a conduit for axonal growth across a nerve gap, without the use of sutures. They are soft and flexible and degrade through hydrolysis with a bioabsorption profile that is compatible with nerve healing.
The silicone applicator and syringe tip are designed to promote consistent and precise application of the COAPTIUM® polymer onto the coaptation chamber and adjacent peripheral nerve. The TISSIUM®

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Light Cover is for use with the reusable TISSIUM® LIGHT, which polymerizes the COAPTIUM® polymer on-demand.

The components of COAPTIUM® CONNECT are supplied in single use sterile double peel packages and come in a variety of sizes. The TISSIUM® Light Cover is supplied in a single peel pouch and used as a sterile cover for the reusable TISSIUM® LIGHT.

The TISSIUM® LIGHT is supplied separately and packaged in a single wall corrugated cardboard box.

## Indications for Use:

COAPTIUM® Connect with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

## Substantial Equivalence:

This Special 510(k) addresses a modification to the TISSIUM® Light Cover, a component of the granted COAPTIUM® Connect with TISSIUM® LIGHT device. The intended use is identical and technological characteristics of the modified TISSIUM® Light Cover are substantially equivalent to the original version of the TISSIUM® Light Cover (DEN240066).

## Summary of Technological Characteristics:

The subject device is identical to the predicate device with respect to intended use, and technological characteristics, including device type, shape (transparent, flexible sleeve), biocompatibility, performance characteristics, mode of operation and sterilization method. The subject device has some slight differences in materials and dimensions which do not raise any new or increased risks of safety and performance. The provided risk analysis and performance verification testing demonstrates the subject device is substantially equivalent to the predicate.

## Testing and Test Results:

Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA guidance document, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, issued on September 8, 2023.

Performance verification was performed, and shelf-life and sterilization validations have been performed to existing specifications.

All testing met the existing predetermined acceptance criteria

## Conclusion:

Based on performance testing and the technological characteristics, the modified COAPTIUM® Connect with TISSIUM® LIGHT meets the established performance criteria and is substantially equivalent to the predicate device.

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