LACTOSCREW SCREW ANCHOR by BIOMET ORTHOPEDICS, INC.

Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.

Device Description

This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.

AI/ML Overview

The provided text is a 510(k) summary for the Biomet LactoScrew™ Screw Anchor, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new study with acceptance criteria and performance metrics.

Therefore, the document explicitly states:

Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."

Due to this, the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for a study proving acceptance criteria cannot be answered directly from the provided text.

The 510(k) process for this device relies on demonstrating that its technological characteristics (material and design) are similar to existing, legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here would relate to the successful demonstration of substantial equivalence, primarily through non-clinical mechanical testing, rather than performance against pre-defined clinical metrics.

Summary

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JUN 3 0 2004

BIOMET

510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Mary L.Verstynen Contact Person: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Telephone: (574) 267-6639 extension 1343 Fax: (574) 372-1683

Proprietary Name: LactoScrew™ Screw Anchor

resorbable screw anchor Common Name:

Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable Screw Anchor, K012872

Device Description:

Intended Use:

Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/

Image /page/0/Figure/18 description: The image shows contact information for a company, including mailing and shipping addresses. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587, while the shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office phone number is 574.267.6639, the fax number is 574.267.8157, and the email address is biomet@biomet.com.

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Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, illotibial band tendodesis, and patellar ligament/ tendon repair.

Summary of Technologies: The LactoScrew™ Screw Anchors technological Characteristics (material and design) are similar to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

All trademarks are property of Biomet, Inc.

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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 abstract symbol resembling an eagle or bird with three stylized wing-like shapes. The logo is black and white and appears to be a scanned or low-resolution image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2004

Ms. Mary L. Verstynen Biomet Orthopedics Incorporated 56 East Bell Drive PO Box 587 Warsaw, Indiana 46581-0587

Re: K033355

Trade Name: LactoScrew™ Screw Anchor Regulation Number: 888.3040 Regulation Name: Smooth or metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: April 5, 2004 Received: April 6, 2004

Dear Ms. Verstynen:

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 such 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.

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Page 2 - Ms. Mary L. Verstynen

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K033355

Device Name: LactoScrew™ Screw Anchor

Indications For Use:

Indications for the LactoScrew™ Screw Anchor include use in soft tissue reatiachment mulcations for the Edotoodrow - Bere, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff Singduder. Dalikal repair, och "Totleh repair, and one struction, biceps tendodesis, deltoid repair.
Prepair, capsule repair or capsulolabral reconstruction, biceps linemat repair, capsule repair of ouplaint reconstruction, ulnar/radial collateral ligament reconstruction.

reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. repairneconstruction, hallax valgus roomaticallateral ligament reconstruction, biceps tendon reconstruction.

tendon reconstruction.
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/ tendon repair.

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Miriam C. Provost
	(Division Sign-Off)
	Division of General, Restorative,
	and Neurological Devices

Prescription Use(Per 21 CFR 801.109)
Over-The-Counter Use(Optional Format 1-2-96)

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

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