CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES

K092898 · Conmed Linvatec · MAI · Oct 19, 2009 · Orthopedic

Device Facts

• Record ID: K092898
• Device Name: CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
• Applicant: Conmed Linvatec
• Product Code: MAI · Orthopedic
• Decision Date: Oct 19, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. 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 push-in suture anchor; preloaded on disposable inserter with one or two #2 Hi-Fi braided polyethylene sutures. Used in orthopedic surgery (arthroscopic or open) by surgeons to reattach soft tissue (ligaments, tendons, joint capsules) to bone. Anchor provides mechanical stabilization of tissue during healing period. Device manufactured from Poly L-lactic Acid (PLLA) with D&C violet #2 colorant. Inert, noncollagenous polymer. Benefits patient by securing soft tissue to bone to facilitate healing.

Clinical Evidence

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

Technological Characteristics

Bioabsorbable push-in anchor; 2.9mm diameter, 10.75mm length. Material: 100% Poly L-lactic Acid (PLLA) with D&C violet #2 colorant. Includes disposable inserter and #2 Hi-Fi braided polyethylene sutures. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring soft tissue-to-bone reattachment in orthopedic procedures, including ligaments, tendons, or joint capsules, via arthroscopic or open surgery.

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 Bio Mini-Revo Suture Anchor (K053561)
• ConMed Linvatec BioAnchor (K042778)

Submission Summary (Full Text)

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### 510(k) SUMMARY

### ConMed Linvatec Presto ™, Preloaded with one or two #2 Hi-Fi® Sutures

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 K092898.

#### Submitter A.

# OCT 1 7 2009

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

#### Company Contact B.

Lorna Linville Regulatory Affairs Manager Phone: [phone] Fax: [phone]

#### C. Device Name

| Trade Name: | ConMed Linvatec Presto, Preloaded with one or |
|------------------------|-----------------------------------------------|
| | two #2 Hi-Fi® Sutures |
| Common Name: | Bioabsorbable suture anchor |
| Classification Name: | Single/multiple component metallic bone |
| | fixation appliances and accessories |
| Proposed Class/Device: | Class II |
| Product Code: | MAI |
| Regulation: | 21 CFR Part 888.3030 |

### Predicate/Legally Marketed Devices D.

| Device Name: | ConMed Linvatec Bio Mini-Revo Suture Anchor |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
| TY --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Canlind Tinustan Rin Anchor |

ConMed Linvatec BioAnchor Device Name: ConMed Linvatec Company Name: K042778 510(k) #:

162

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#### E. Device Description

The proposed device is a bioabsorbable push-in (press fit) suture anchor that is preloaded on a disposable inserter device with one or two non-absorbable. braided, polyethylene sutures. The proposed device is manufactured from 100% Poly L-lactic Acid with colorant D&C violet #2. The polymer is inert and noncollagenous through the absorption process. The device dimensions are 2.9mm diameter and 10.75mm in length.

#### F. Intended Use/ Indications

The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. 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 proposed device is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the identified predicate devices K053561 and K042778.

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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 three lines representing its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the upper half of the circle.

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

ConMed Linvatec % Ms. Loma K. Linville Regulatory Affairs Manager 11311 Concept Boulevard Largo, Florida 33773-4908

## OCT 1 7 2009

Re: K092898

Trade/Device Name: ConMed Linvatec Presto™, Preloaded with one or two #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: September 18, 2009 Received: September 21, 2009

Dear Ms. Linville:

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 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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Page 2- Ms. Lorna K. Linville

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, "Mishranding 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 A. Millhurn

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

Ko92898

510(k) Number (if known):

ConMed Linvatec Presto™, Preloaded with one or two #2 Hi-Fi Device Name: Sutures

Indications for Use:

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. 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)

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(Division Sign Off)

Division of Surgical, Onthopedic. and Restorative Devices

510(k) Number K092898