CONMED LINVATEC INTERCEPT IMPLANT

K092998 · Linvatec Corp. · MBI · Dec 23, 2009 · Orthopedic

Device Facts

• Record ID: K092998
• Device Name: CONMED LINVATEC INTERCEPT IMPLANT
• Applicant: Linvatec Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ConMed Linvatec Intercept Implant is for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures. The Intercept Implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

Device Story

ConMed Linvatec Intercept Implant is a nonabsorbable suture anchor system for orthopedic soft tissue-to-bone fixation. Device consists of PEEK interference screws (5-8mm diameter; 12-23mm length) and a disposable driver. Used by surgeons in arthroscopic or open procedures to secure ligaments or tendons to bone. Principle of operation involves mechanical interference fixation; implant provides physical anchor point during healing period. Postoperative immobilization is required. Benefits include secure tissue reattachment to bone, facilitating healing.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Material: PEEK (polyetheretherketone). Form factor: Interference screw, 5mm-8mm diameter, 12mm-23mm length. Includes disposable driver. Mechanical fixation principle. Nonabsorbable.

Indications for Use

Indicated for orthopedic surgical procedures requiring interference fixation of soft tissue (ligaments or tendons) to bone in patients where implant sizes are appropriate. Used in arthroscopic or open procedures. Requires postoperative immobilization.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Matryx® Interference Screw (K063588)
• Arthrex Interference Screw (K062466)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

DEC 2 3 2009

010

# ConMed Linvatec Intercept Implant

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 K092998

## A. Submitter

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

## B. Company Contact

Dionne Sanders Regulatory Affairs Specialist [phone] Telephone [phone] FAX

### C. Device Name

Trade Name: Common Name: Classification Name: Proposed Class/Device: Product Code: Regulation:

#### ConMed Linvatec Intercept Implant

Nonabsorbable suture anchor system Fastener, fixation, nondegradable, soft tissue Class II MBI 21 CFR Part 888.3040

#### D. Predicate/Legally Marketed Devices

| Device Name: | Matryx® Interference Screw |
|---------------|----------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K063588 |

Device Name: Company Name: 510(k) #:

Arthrex Interference Screw Arthrex, Inc. K062466

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#### E. Device Description

The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.

#### F. Intended Use/ Indications

The ConMed Linvatec Intercept Implant is for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures. The Intercept Implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

## G. Substantial Equivalence

The ConMed Linvatec Intercept Implant is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Matryx Interference Screw (K063588) and the Arthrex Interference PEEK Screw (K062466) predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a bird-like figure with outstretched wings.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Linvatec Corporation % Ms. Dionne Sanders Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

DEC 2 3 2009

Re: K092998

Trade/Device Name: ConMed Linvatec Intercept Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 9, 2009 Received: December 10, 2009

Dear Ms. Sanders:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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#### INDICATIONS FOR USE

# 510(k) Number (if known): K092998

Device Name: ConMed Linvatec Intercept Implant

Indications for Use:

The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number _/i092958