ACUMED SUTURE ANCHOR

K993657 · Acu Med, Inc. · MBI · Jan 13, 2000 · Orthopedic

Device Facts

• Record ID: K993657
• Device Name: ACUMED SUTURE ANCHOR
• Applicant: Acu Med, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended foranchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

Device Story

Acumed Suture Anchor is a single-use, screw-based implantable device designed to anchor soft tissue to bone. It utilizes non-absorbable, non-coated #2 or #0 braided polyester suture. The device is manufactured from titanium 6AL 4V ELI. It is intended for use by surgeons in orthopedic procedures, specifically rotator cuff repairs and foot/ankle soft tissue repairs. The device is provided non-sterile and requires steam sterilization by the user prior to implantation. By providing a secure mechanical anchor, the device facilitates the reattachment of soft tissue to bone, aiding in the healing and stabilization of the repaired site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium 6AL 4V ELI per ASTM F136. Design: Screw-based suture anchor. Energy source: None (mechanical). Connectivity: None. Sterilization: Steam sterilization (SAL 10^-6).

Indications for Use

Indicated for anchoring soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle.

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

• Mitek GII Anchor (K980103)
• Mitek SuperAnchor (K980103)
• Linvatec Revo
• Zimmer Statak

Submission Summary (Full Text)

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## acumen®

Quality Orthopaedic Instruments and Implants

## Appendix F - 510 (k) Summary

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed. Information regarding labeling has been provided.

Predicate devices that are substantially equivalent to the Acumed Suture Anchor are the Mitek GII Anchor and SuperAnchor, the Linvatec Revo, and the Zimmer Statak. All the devices mentioned above have the same indications and are manufactured from titanium. The design of the Acumed Suture Anchor is screw based and is similar to the Linvatec Revo and the Zimmer Statak. The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques. Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above.

Acumed, Inc. � 10950 S.W. 50 € Beaverton, OR 97005 � [phone] ◆ Fax [phone] C1998, Acumed, Inc. Appendix F

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K993657

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 3 2000

Ms. Shari Jeffers Regulatory Affairs Manager Acumed. Inc. 10950 S.W. 5th Street Suite 170 Beaverton, Oregon 97005

Re: K993657 Trade Name: Acumed Suture Anchor Regulatory Class: II Product Code: MBI Dated: October 18, 1999 Received: October 28, 1999

Dear Ms. Shari Jeffers:

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.

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

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Page 2 - Ms. Shari Jeffers

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell W. Rogers

& 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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510(k) Number (if known):_ K 993657

Device Name: Acumed Suture Anchor

Indications For Use:

This device is intended foranchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Plunell Sawyer teriz.

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

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)