(105 days)
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.
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.
Here's an analysis of the provided text regarding the Allofix™ Anchor, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only briefly mentions "design input requirements for strength" and "design requirements" for dimensions. It does not provide specific quantitative acceptance criteria. Therefore, the table below reflects the qualitative statements made.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Design input requirements for strength | The conclusion of the anchor insertion and fixation test confirmed that the Allofix™ Anchor meets design input requirements for strength. Pullout values for fixation strength exceeded those of metal and polymeric devices used for similar types of fixation. |
| Design requirements for dimensions | The tests also confirmed that the Allofix™ Anchor dimensions were within design requirements. |
| Insertion repeatability | Insertion repeatability was found to be acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Biomechanical testing of the Allofix™ Anchor was performed". It does not specify the sample size used for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's implied to be in vitro biomechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The "ground truth" for the biomechanical tests would likely be established by the testing methodology itself (e.g., universal testing machine readings for strength, precise measurement tools for dimensions), rather than expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Biomechanical testing generally relies on objective measurements rather than expert adjudication.
5. 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
An MRMC comparative effectiveness study was not done. This device is a medical implant (bone anchor), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The Allofix™ Anchor is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "strength" and "dimensions" tests would be based on objective physical measurements obtained through biomechanical testing equipment and metrology, compared against the pre-defined design specifications. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This is not applicable as the Allofix™ Anchor is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the Allofix™ Anchor is not an AI/ML device.
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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: 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 96 11 Street Edison, NJ 08837 Tel: 732-661-2381 Nancy_Bennewitz@mtf.org
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 (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 (301) 443-6597 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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(b)
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.