ALLOFIX ANCHOR, 5.0 MM ANCHOR

K061498 · Musculoskeletal Transplant Foundation · JDW · Jul 6, 2006 · Orthopedic

Device Facts

• Record ID: K061498
• Device Name: ALLOFIX ANCHOR, 5.0 MM ANCHOR
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: JDW · Orthopedic
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Allofix™ Anchor is a bone anchor system for orthopedic soft tissue-to-bone attachment. The kit includes a machined human allograft bone anchor, #2 polyethylene/polyester sutures, and a single-use inserter. The surgeon uses a provided drill or punch to create a bone hole, then uses the inserter to place the allograft anchor. The anchor provides fixation strength for soft tissue repair. The device is intended for use by orthopedic surgeons in a clinical/surgical setting.

Clinical Evidence

Bench testing only. Biomechanical testing evaluated anchor insertion and fixation strength. Results confirmed the device meets design requirements for strength and dimensions. Insertion repeatability was acceptable, and pullout fixation strength exceeded that of metal and polymeric predicate devices.

Technological Characteristics

Materials: Machined human allograft bone (tibia/femur) and USP Size 2 braided polyethylene/polyester sutures. Form factor: Anchor loaded with sutures in a single-use inserter. Energy source: None (manual). Sterilization: Sterile, single-use.

Indications for Use

Indicated for soft tissue to bone attachment in orthopedic procedures requiring soft tissue approximation or ligation.

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

• Smith and Nephew Phoenix 5.0 Allograft Anchor (K011985)

Submission Summary (Full Text)

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

### A. SPONSOR IDENTIFICATION

JUL - 6 2006

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 96th Street Edison, NJ 08837 Tel: [phone] Nancy [e-mail]

- D. DATE OF PREPARATION OF THIS SUMMARY March 30, 2006
## 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
- J. DEVICE PRODUCT CODE MAI, JDW, GAT

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K061498 (pg 2 of :

5.0 mm Allofix™ Anchor 510(k)

#### 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 Smith and Nephew Phoenix 5.0 Allograft Anchor (FDA cleared, K011985).

# O. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Both the Allofix™ Anchor and the Phoenix 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™ Anchor and its predicate require implantation into bone through use of an attached insertion device. The Allograft Anchor™ and its predicate use USP Size Number 2 Braided Polyethylene/Polyester 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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JUL - 6 ZUUF

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Transplant Foundation % Nancy L. Bennewitz Regulatory Affairs Submission Specialist 125 May Street, Suite 300 Edison Corp Center Edison, New Jersey 08837

Re: K061498

Trade/Device Name: Allofix™ Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: JDW, MAI Dated: May 30, 2006 Received: May 31, 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 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. Nancy L. Bennewitz

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/industry/support/index.html.

Sincerely yours,

Barbara Buelin MD

Mark N. Melkerson 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): ____________________________________________________________________________________________________________________________________________________

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)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jeanne Truehill

vision Division of General, Restorative, and Neurological Devices

510(k) Number.