The Allofix™ Anchor is indicated for use in the attachment of soft . tissue to bone in orthopedic procedures.
The Allofix™ Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Allofix™ Anchor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a direct comparison table for the Allofix™ Anchor. Instead, it refers to the device meeting "design input requirements for strength" and exceeding values of "metal and polymeric devices used for similar types of fixation."

Inferred Acceptance Criteria based on "Summary of Studies (P)":

Acceptance Criterion	Reported Device Performance
Anchor Insertion and Fixation Strength	Meets design input requirements for strength.
	Pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation.
Dimensions	Within design requirements.
Insertion Repeatability	Found to be acceptable.

Study Details

The provided text describes "Biomechanical testing" as the study performed.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not explicitly stated, however, the testing was conducted to investigate design requirements, implying it was likely a laboratory-based biomechanical study. There is no information regarding the country of origin of data or whether it was retrospective or prospective in the context of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a biomechanical study, not a study involving expert review or ground truth establishment by medical professionals. The "ground truth" would be the measured physical properties (strength, dimensions, repeatability) of the anchor itself against engineering specifications.
Adjudication method for the test set:
- Not applicable. This was a biomechanical study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is a bone anchor, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's physical properties as measured in the biomechanical tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this biomechanical study refers to the engineering specifications and performance benchmarks set for device strength, dimensions, and insertion repeatability. The device's performance was measured against these predefined physical and mechanical properties.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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: 732-661-0202 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: 732-661-2381 Nancy Bennewitz@mtf.org

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

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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wings, representing health, human services, and well-being. The eagle is positioned above a wavy line, symbolizing the ocean. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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 (240) 276-0120 . 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 (240) 276-3150 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.

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.