(36 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and delivery system of a surgical anchor, with no mention of AI or ML capabilities.
No
The device, the Allofix™ Anchor, is used to attach soft tissue to bone and for soft tissue approximation/ligation in orthopedic procedures. While it aids in recovery, it does not directly treat or prevent a disease or condition; rather, it is a surgical tool/implant.
No
The provided text describes a device, the Allofix™ Anchor, used for surgical attachment of soft tissue to bone. Its function is to perform a physical action (attachment), and there is no mention of it being used to diagnose a medical condition or provide diagnostic information.
No
The device description clearly outlines physical components including an anchor, suture, inserter, plastic body, stainless steel tube, drill or punch, and plastic tray. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attachment of soft tissue to bone in orthopedic procedures" and "soft tissue approximation and/or ligation of orthopaedic procedure." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a physical anchor, suture, and inserter designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on biological samples to provide information about a person's health. This device is a surgical tool/implant used in vivo (within the body) during a procedure.
N/A
Intended Use / Indications for Use
The Allofix™ Anchor is indicated for use in the attachment of soft . tissue to bone in orthopedic procedures.
Product codes
MAI, JDW, GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.