ENDOPEARL WITH THREADER

K993339 · Linvatec Corp. · MAI · Dec 10, 1999 · Orthopedic

Device Facts

• Record ID: K993339
• Device Name: ENDOPEARL WITH THREADER
• Applicant: Linvatec Corp.
• Product Code: MAI · Orthopedic
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used in conjunction with a Linvatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.

Device Story

EndoPearl™ With Threader is a cannulated, sterile, single-use bioabsorbable fixation device; composed of Poly (L-lactic acid). Device comes preloaded on a suture threader featuring a nitinol wire; facilitates suture threading into the device during graft preparation. Used by surgeons, residents, PAs, or nurses in clinical settings during ACL/PCL reconstruction. Acts as a back-up fixation mechanism for soft tissue grafts when used with a BioScrew® interference screw. Device is metabolized by the body over time.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

Cannulated, bioabsorbable fixation device. Material: Poly (L-lactic acid). Threader: Ultem handle with nitinol wire. Sizes: 7mm, 8mm, 9mm. Sterilization: Ethylene Oxide (ETO). Single-use.

Indications for Use

Indicated for use as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction in conjunction with a Linvatec BioScrew® bioabsorbable interference screw.

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

• EndoPearl™ (K984171)

Submission Summary (Full Text)

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K9913339

DEC I 0 1999

October 4, 1999

### SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and nereby - Baxaccing - cho Pearl™ With Threader, 510(k) Number

#### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### Company Contact B.

Laura Seneff Manager, Regulatory Affairs

#### Device Name C.

| Trade Name: | : EndoPearl™ With Threader |
|---------------------------------------|------------------------------------------------------------------------|
| Common Name | : |
| Classification Names | : None Assigned |
| Proposed Class/Device<br>Product Code | : Class II-87 MAI, Fastener<br>Fixation, Biodegradable, Soft<br>Tissue |

### Predicate/Legally Marketed Devices D.

EndoPearl™ Linvatec Corporation

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Summary of Safety and Effectiveness
EndoPearl™ With Threader 510(k) # k993339 October 4, 1999 Page 2 of 3

## E. Device Description

The EndoPearl™ With Threader Bioabsorbable Soft Tissue Device is a cannulated, sterile, sinqle-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body.

EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.

### F. Intended Use

1. 1

This device is used in conjunction with a Linvatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.

#### ৫ . Substantial Equivalence

The EndoPearl™ With Threader is substantially equivalent in function and intended use to the EndoPearl™ (Linvatec Corporation) .

The similarities/dissimilarities to the predicate are shown in the attached table.

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# Summary of Safety and Effectiveness EndoPearl™ With Threader 510 (k) # ____________________________________________________________________________________________________________________________________________________________________ Page 3 of 3

## �

## CHART OF SIMILARITIES AND DISSIMILARITIES

| Company | Device Name | Intended Use | Material | Single-Use<br>Reusable<br>Method of<br>Sterilization | Design |
|------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|---------------|
| NEW PRODUCT<br>Linvatec | EndoPearl™<br>With Threader<br>Bioabsorbable<br>Soft Tissue<br>Device | Used in conjunction<br>with a Linvatec<br>BioScrew®<br>bioabsorbable<br>interference screw, as<br>a back-up to<br>interference screw<br>fixation of soft<br>tissue grafts on the<br>femoral side of an<br>ACL/PCL<br>reconstruction. | EndoPearl: Poly (L-lactic<br>acid)<br>Threader: Ultem with Nitinol<br>Wire | Single-Use<br>ETO | 7mm, 8mm, 9mm |
| PREDICATE<br>Linvatec<br>EndoPearl™<br>510(K) #<br>K984171 | EndoPearl™ | Used in conjunction<br>with a Linvatec<br>BioScrew®<br>bioabsorbable<br>interference screw, as<br>a back-up to<br>interference screw<br>fixation of soft<br>tissue grafts on the<br>femoral side of an<br>ACL/PCL<br>reconstruction. | Poly (L-lactic acid) | Single-Use<br>ETO | 7mm, 8mm, 9mm |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

Ms. Laura Seneff Manager. Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K993339

Trade Name: EndoPearI™ With Threader Regulatory Class: II Product Code: MAI and HWC Dated: October 4, 1999 Received: October 5, 1999

Dear Ms. Seneff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laura Seneff

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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October 4, 1999

Page 1 of 2

510(k) Number (if known):_K993339

Device Name: EndoPearl™ With Threader

Indications for Use:

The EndoPearl™ With Threader is used in conjunction with a Invatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use___________OR

Over-the-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-296)

Acolla