METAL SCREW ANCHOR

K012503 · Biomet Manufacturing, Inc. · MBI · Oct 22, 2001 · Orthopedic

Device Facts

• Record ID: K012503
• Device Name: METAL SCREW ANCHOR
• Applicant: Biomet Manufacturing, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsulo repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications -- Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Device Story

Metal Screw Anchor is a screw-type fixation device for attaching soft tissue to bone during healing. Available in 3.0 mm and 5.0 mm sizes; consists of screw and head portions. Preloaded on a driver with various suture configurations (monofilament, #1, #2, or #5). Used by surgeons in orthopedic procedures to secure soft tissue to bone. Benefits include mechanical stabilization of tissue during the healing process.

Clinical Evidence

Bench testing only; no clinical data was used to establish substantial equivalence.

Technological Characteristics

Screw-type anchor; metallic construction; available in 3.0 mm and 5.0 mm diameters; preloaded on a driver with suture; sterile packaging.

Indications for Use

Indicated for soft tissue reattachment to bone in shoulder, wrist, hand, ankle, foot, elbow, and knee procedures. Includes ligament, tendon, and capsule repairs/reconstructions. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Harpoon Suture Anchor (K943806/K973775)

Submission Summary (Full Text)

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OCT 22 2001

Image /page/0/Picture/2 description: The image shows the words "BIOMET" in a stylized, bold font. Below this, the words "CORPORATE HEADQUARTERS" are printed in a smaller, less bold font. The text appears to be part of a logo or heading.

## SUMMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Arthrotek, Inc. (A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Establishment Registration No .: 1825034

Contact Person:

Sara B. Shultz Biomet Manufacturing, Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: [phone] FAX: [phone]

Proprietary Name:

Metal Screw Anchor

screw anchor Common or Usual Name:

Fastener. Fixation. Non-degradable, Soft Tissue Classification Name:

87MBI and 87HWC Device Product Code:

Legally Marketed Devices To Which Substantial Equivalence is Clalmed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775)

Indications for Use: Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows:

Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsulo repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand Indications - Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 II. Bell Drive Warsaw, IN 46582

OFFICIE 219.267.6639

l'Ax 219.267.8137

E-MAIL [e-mail]

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K012503

2 OF 2

Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, black letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, black letters.

Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee Indications -- Medial collateral ligament repair, lateral collateral ligament repair, Ande indications - Medial Sollatora. neems. If intibial band tenodesis, and patellar ligament/tendon repair.

Device Description: The Metal Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured out of theuile for ucasioning con is available in two sizes, 3.0 mm. The screw anchor consists of a screw portion and a head portion.

The 3.0 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.0 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Metal Scrow Anchor will be packaged sterile and will be preloaded on a driver with suture.

Summary of Technologies: The Metal Screw Anchor's technological characteristics (materials, design, sizes, and indications) are similar to the predicate device.

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.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SIXIPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

1:4X 219.267.8137

E-MAIL [e-mail]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the snakes intertwined around a staff. The caduceus is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

OCT 22 2001

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P. O. Box 587 Warsaw, Indiana 46581-0587

Re: K012503

ﺑ

Trade Name: Metal Screw Anchor

Regulation Number: 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: MBI Dated: August 2, 2001 Received: August 3, 2001

Dear Ms. Shultz:

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.

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.

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## Page 2 - Ms. Sara Shultz

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Millerson

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

Enclosure

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## Kol 2503 510(k) NUMBER (IF KNOWN):

## DEVICE NAME: Metal Screw Anchor

INDICATIONS FOR USE: Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee.

Specific indications are as follows:

Shoulder Indications - Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule repair, or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.

Wrist/Hand Indications - Scapholunate ligament reconstruction, and ulnar/radial collateral ligament reconstruction.

Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow Indications - Ulnar or radial collateral ligament reconstruction, and biceps tendon reconstruction.

Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, liiotibial band tenodesis, and patellar ligament/tendon repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Ov
(Per 21 CFR 801.109) (O

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Dіvоn foeneral, Restorative

Over-The-Counter-Use (Optional Format 1-2-96)

and Neurological Devices

510kk) Number