CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE

K102339 · Conmed Linvatec · GAT · Nov 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102339
• Device Name: CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
• Applicant: Conmed Linvatec
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

Device Story

The ConMed Linvatec Sequent™ Meniscal Repair Device is a handheld, disposable, sterile instrument used by surgeons for all-inside meniscal repair. It enables the sequential deployment of implants and suture to create multiple fixation points along a soft tissue tear. The device features an implant with a cleat mechanism that retains the suture, facilitating a knotless repair. After deployment, the instrument is removed, leaving the suture/implant construct in the patient. This system allows for precise fixation of meniscal tissue, potentially improving clinical outcomes for patients undergoing arthroscopic or percutaneous soft tissue repair procedures.

Clinical Evidence

Bench testing only. Evidence includes verification and validation testing: cyclic loading characteristics, ultimate fixation strength of meniscal repairs, functional system testing, material degradation, risk analysis, and packaging/transportation qualification.

Technological Characteristics

All-inside meniscal repair device; handheld, disposable, sterile, single-use. Features implant with cleat for suture retention (knotless). Materials and specific standards not detailed in provided text. Mechanical principle of operation for soft tissue fixation.

Indications for Use

Indicated for percutaneous or endoscopic soft tissue repairs, including meniscal tears, in patients requiring surgical intervention.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Meniscal Cinch™ (K073149)
• Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems (K072322)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY ConMed Linvatec

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number < 102 3.3 9

Date Prepared: August 12, 2010 Date Revised: November 5, 2010

# A. Submitter

NOV 2 3 2010

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

# B. Company Contact

Jan Flégeau Regulatory Affairs Manager [phone] Telephone [phone] FAX

#### C. Device Name

| Trade Name: | ConMed Linvatec Sequent™ Meniscal Repair Device |
|------------------------|-------------------------------------------------------------|
| Common Name: | Suture Retention Device |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) surgical suture. |
| Proposed Class/Device: | Class II |
| Product Code: | GAT |
| Regulation: | 21 CFR Part 878.5000 |

# D. Predicate/Legally Marketed Devices

| Device Name: | Meniscal Cinch™ |
|---------------|-----------------------------------------------------------------|
| Company Name: | Arthrex Inc. |
| 510(k) #: | K073149 |
| Device Name: | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal<br>Repair Systems |
| Company Name: | Smith & Nephew |
| 510(k) #: | K072322 |

ર-I

{1}------------------------------------------------

### E. Device Description

The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.

#### F. Intended Use

The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

#### G. Testing

ConMed Linvatec conducted verification and validation testing including cyclic loading characteristics, ultimate fixation strength of meniscal repairs, functional system testing, material degradation, risk analysis and packaging/transportation qualification. Based on this testing, we have determined that the device is safe and effective and performs as well as or better than the legally marketed predicate devices identified in Section D of this summary.

#### H. Substantial Equivalence

The ConMed Linvatec Sequent™ Meniscal Repair Device is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices.

Minor differences between the ConMed Linvatec Sequent™ Meniscal Repair Device and the predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ConMed Linvatec % Ms, Jan Flegeau Regulatory Affairs Manager 1311 Concept Boulevard Largo, Florida 33773

NOV 2 3 2010

Re: K102339

Trade/Device Name: ConMed Linvatec Sequent™ Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, MBI Dated: November 19, 2010 Received: November 22, 2010

Dear Ms. Flegeau:

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 (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. 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.

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.

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 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Jan Flegeau

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

barbare Buett

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

K102339 510(k) Number (if known): ___

Device Name: ConMed Linvatec Sequent™ Meniscal Repair Device

NOV 2 3 2010

Indications for Use:

The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

Prescription Use_X_AND/OR Over-the-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onetu for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102339