CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES

K090186 · Linvatec Corp. · MAI · Apr 10, 2009 · Orthopedic

Device Facts

• Record ID: K090186
• Device Name: CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
• Applicant: Linvatec Corp.
• Product Code: MAI · Orthopedic
• Decision Date: Apr 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Device Story

Bioabsorbable screw-in suture anchor; preloaded on disposable inserter with two nonabsorbable braided polyethylene sutures. Used by surgeons in arthroscopic or open procedures to reattach soft tissue (ligaments, tendons, joint capsules) to bone. Anchor provides mechanical fixation; stabilizes tissue during healing period. Device is inert and non-collagenous during absorption.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Bioabsorbable screw-in anchor; material: Self-Reinforced (96L/4D) PLA Copolymer; colorant: D&C violet #2; sizes: 5.0mm - 6.5mm; includes disposable inserter and two nonabsorbable braided polyethylene sutures.

Indications for Use

Indicated for patients requiring soft tissue-to-bone reattachment, including ligaments, tendons, or joint capsules, during arthroscopic or open surgical procedures.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• ConMed Linvatec Duet Suture Anchor (K042966)
• ConMed Linvatec Bio Mini-Revo Suture Anchor (K053561)

Submission Summary (Full Text)

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(pg. 1 of 2)

APR 1 0 2009

#### 510(k) SUMMARY

# ConMed Linvatec Paladin™, Preloaded with two #2 Hi-Fi® Sutures

In accordance with the requirements of the Safe Medical Device Act of 1990 and in accerdance that thereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number K090186.

#### A. Submitter

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

### B. Company Contact

Joy Lovett Regulatory Affairs Specialist [phone] Telephone [phone] FAX

#### C. Device Name

| Trade Name: | ConMed Linvatec Paladin, Preloaded with two<br>#2 Hi-Fi® Sutures |
|------------------------|------------------------------------------------------------------|
| Common Name: | Bioabsorbable suture anchor |
| Classification Name: | Biodegradable soft tissue fixation fastener |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |

### D. Predicate/Legally Marketed Devices

| Device Name: | ConMed Linvatec Duet Suture Anchor |
|---------------|---------------------------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K042966 |
| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |

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K090186 (pg. 2 of 2)

#### E. Device Description

The ConMed Linvatec Paladin Suture Anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with two nonabsorbable, braided, polyethylene sutures. The ConMed Linvatec Paladin Suture Anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The copolymer is inert and non-collagenous through the absorption process. The device will be available in 5.0mm - 6.5mm in size with colorant D&C violet #2.

#### F. Intended Use/ Indications

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

#### G. Substantial Equivalence

The ConMed Linvatec Paladin Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K042966 and K053561.

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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 stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2009

ConMed Livatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K090186

Trade/Device Name: ConMed Linvatec Paladin, Preloaded with tow #2 Hi-Fi Sutures Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: March 12, 2009

Received: March 13, 2009

Dear Ms. Lovett:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

for

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

Enclosure

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## Indications for Use

K090186 510(k) Number (if known): __

ConMed Linvatec Paladin, Preloaded with two #2 Hi-Fi Sutures Device Name:

Indications for Use:

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Prescription Use_X_ AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Claula Bussell for mkm
Division Sign Off

Division of General, Restorative, and Neurological Devices

**510(k) Number** k091086