← Product Code [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW) · K061498 # ALLOFIX ANCHOR, 5.0 MM ANCHOR (K061498) _Musculoskeletal Transplant Foundation · JDW · Jul 6, 2006 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K061498 ## Device Facts - **Applicant:** Musculoskeletal Transplant Foundation - **Product Code:** [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW.md) - **Decision Date:** Jul 6, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K011985.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ # 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K061498](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K061498) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com