The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the device is accomplished through arthroscopy or arthrotomy.

Device Description

The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(Llactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.

AI/ML Overview

The provided document describes the BioStinger™-V Bioabsorbable Meniscal Repair Device, and its submission for 510(k) clearance based on substantial equivalence to a predicate device. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria comparing the new device against specific metrics in a clinical setting. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, and detailed study methodologies for proving device performance is not present in the provided text.

Here's an explanation of why this information is absent in the context of this specific regulatory document:

510(k) Submission Focus: A 510(k) (Premarket Notification) is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The primary goal is to demonstrate that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
No "Study Proving Acceptance Criteria" for 510(k) Equivalence: Unlike a PMA (Premarket Approval) submission, which often requires extensive clinical trials to prove efficacy and safety against specific acceptance criteria, a 510(k) typically relies on comparisons to the predicate device, including material properties, design, function, and sometimes non-clinical testing (e.g., biocompatibility, mechanical testing). The document explicitly states, "The BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device."
Emphasis on Predicate Comparison: The "Chart of Similarities and Dissimilarities" clearly shows that the new device and the predicate have identical intended use, material (poly L-lactic acid), sterilization, and similar design characteristics. The key difference noted for the new device is the addition of a color additive (D&C Violet #2).

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because the provided text for the BioStinger™-V Bioabsorbable Meniscal Repair Device 510(k) submission does not contain this information.

If this were a different type of submission (e.g., a PMA or a de novo application), or if the 510(k) included specific performance data to address a new technological characteristic, such information might be present. However, for this particular document, the demonstration of safety and effectiveness relies on substantial equivalence to the predicate device.

Summary

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AJG - 6 -

May 19, 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 Effectiveness for the BioStinger™-V Bioabsorbable Meniscal Repair Device.

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Company Contact B.

Laura Seneff Manager, Requlatory Affairs

Device Name C.

Trade Name:	BioStinger™-V BioabsorbableMeniscal Repair Device
Common Name:	Meniscal Repair Device
Classification Name/Reference:	None Assigned
Proposed Class/	Class II-87 MAL. Fastener.

Proposed Class Device Product Code: Fixation, Biodegradable, Soft Tissue

Predicate/Legally Marketed Devices D. Linvatec Meniscal Repair Device

E. Device Description

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Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # May 19, 1999 Page 2 of 3

F. Intended Use

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.

Substantial Equivalence G.

The colored BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device.

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

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Summary of Safety and Effectiveness BioStinger™-V Bioabsorbable Meniscal Repair Device 510 (k) # Page 3 of 3

CHART OF SIMILARITIES AND DISSIMILARITIES

・・・・・

CompanyName	Device Name	Intended Use	Material	Single-UseReusable	Method ofSterilization	Design
New ProductLinvatec	BioStinger™-VBioabsorbableMeniscal RepairDevice	Fixation of longitudinalvertical meniscus lesions(bucket handle) located inthe vascularized area of themeniscus.	Poly (L-lactic acid)with color additiveD&C Violet #2	SterileSingle-use	EtO16-month shelflife	CannulatedBarbed tackwith headSizes:1.3mm diameterx 10mm-16mmlength
PredicateLinvatecCorporation510 (k) #K981692	LinvatecMeniscal RepairDevice	Fixation of longitudinalvertical meniscus lesions(bucket handle) located inthe vascularized area of themeniscus.	Poly (L-lactic acid)	SterileSingle-use	EtO16-month shelflife	CannulatedBarbed tackwith headSizes:1.3mm diameterx 10mm-16mmlength

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

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

Re: K991715

Biostinger-V Bioabsorable Meniscal Repair Device Regulatory Class: II Product Code: MAI, HTY Dated: May 19, 1999 Received: May 20, 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 control provisions of the Act. The general control 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.

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.

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Page 2 – Ms. Laura Seneff

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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May 19, 1999 Date:

1 of ਹ Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BioStinger™-V Bioabsorbable Meniscal Repair Device Name: Device

Indications for Use:

The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the device is accomplished through arthroscopy or arthrotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

Over-the-Counter Use__

(Per 21 CFR 801.109)

Asevedo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99/715

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.