ALLOFIX ANCHOR

K053339 · Musculoskeletal Transplant Foundation · GAT · Mar 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053339
• Device Name: ALLOFIX ANCHOR
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allofix™ Anchor is indicated for use in the attachment of soft tissue to bone in orthopedic procedures.

Device Story

Allofix™ Anchor is a bone anchor kit for orthopedic soft tissue-to-bone attachment. Kit includes machined human allograft bone anchor (derived from tibia or femur), two strands of #2 blue polyethylene suture, one strand of white suture, and a plastic/stainless steel inserter. Surgeon uses provided drill or punch to create bone hole; inserter delivers anchor to site. Device is single-use and sterile. Biomechanical testing confirms fixation strength and insertion repeatability. Output is mechanical fixation of soft tissue to bone, aiding surgical repair.

Clinical Evidence

Bench testing only. Biomechanical testing evaluated anchor insertion and fixation strength. Results confirmed design requirements for strength and dimensions were met. Insertion repeatability was acceptable, and pullout values exceeded those of comparative metal and polymeric fixation devices.

Technological Characteristics

Materials: Machined human allograft bone (tibia/femur), #2 polyethylene suture, stainless steel/plastic inserter. Principle: Mechanical bone anchor fixation. Energy: None (manual). Connectivity: None. Sterilization: Sterile, single-use.

Indications for Use

Indicated for soft tissue approximation and/or ligation in orthopedic procedures.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• MTF Allograft Anchor™ (K042038)

Submission Summary (Full Text)

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K053339 page 1 of 2

NILAK B. 65. 1001.

Allofix™ Anchor 510(k)

# VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### A. SPONSOR IDENTIFICATION

Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 Tel: [phone] http://www.mtf.org

#### B. ESTABLISHMENT REGISTRATION NUMBER 2249062

#### C. OFFICIAL CONTACT PERSON

Nancy Bennewitz Regulatory Affairs Submission Specialist Musculoskeletal Transplant Foundation 125 96 11 Street Edison, NJ 08837 Tel: [phone] [e-mail]

#### D. DATE OF PREPARATION OF THIS SUMMARY November 18, 2005

#### E. PROPRIETARY (TRADE) NAME

Allofix™ Anchor

#### F. COMMON NAME

Bone Anchor

## G. CLASSIFICATION NAME

Smooth or Threaded Metallic Bone Fixation Fastener Nonabsorbable Polyethylene Surgical Suture

### H. REGULATION NUMBER

21 CFR 888.3040 and 21 CFR 878.5000

- I. PROPOSED REGULATORY CLASS Class II

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Allofix™ Anchor 510(k)

#### J. DEVJCE PRODUCT CODE MAI, JDW, GAT, HALC

#### K. PANEL CODE

87 or Orthopedic Devices

#### L. DESCRIPTION OF DEVICE

The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with two strands of #2 polyethylene suture, blue, and one strand of white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle.

The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube with two #2 sutures. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.

#### M. INDICATIONS FOR USE

The Allofix™ Anchor is indicated for use in the attachment of soft tissue to bone in orthopedic procedures.

#### N. PREDICATE DEVICE

The Allofix™ Anchor is substantially equivalent to the MTF Allograft Anchor"M (FDA cleared, K042038).

#### O. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Both the Allofix™ Anchor and the Allograft Anchor™ have the same indications for use. Allofix™ Anchor and its predicate are both made from machined human allograft bone derived from the tibia or femur recovered from deceased donors. Both Allofix™M Anchor and its predicate require implantation into bone through use of an attached insertion device. The Allograft Anchor™ uses USP Size Number 2 Braided Polester Susutres and the Allofix™ Anchor use USP Size Number 2 Braided Polyethylene Sutures.

#### P. SUMMARY OF STUDIES

Biomechanical testing of the Allofix™ Anchor was performed to investigate whether the anchor meets design requirements. The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Anchor meets design input requirements for strength. The tests also confirmed that the Allofix™ Anchor dimensions were within design requirements. Insertion repeatability was found to be acceptable and pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Transplant Foundation c/o Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street

Re: K053339

Edison, New Jersey 08837

Trade/Device Name: Allofix™ Anchor Regulation Number: 21 CFR 878.5000, 21 CFR 888.3040 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture. Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: GAT, JDW, HWC Dated: February 24, 2006 Received: February 27, 2006

MAR 1 6 2006

Dear Ms. Bennewitz:

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

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Page 2 - Ms. Nancy Bennewitz

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

Sincerely yours,

Herbert Lerner MD

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# IV. INDICATIONS FOR USE

510(k) Number (if known): K015339

Device Name: Allofix™ Anchor

The Allofix™ Anchor is indicated for use in soft tissue Indications for Use: approximation and/or ligation of orthopaedic procedure.

Prescription Use __ OR X . (Per 21 CFR 801 Subpart D)

No Over-The-Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Sommer
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

§10(k) Number K₀₅₃₃₉