The anchor, suture, needles and inserter are all packaged together. The kit contains one allograft anchor, loaded with one strand of #2 braided polyester suture, green, and one strand of #2 braided polyester suture, white. To each end of suture is attached a CP-2 needle. The anchor, suture and needles are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture and the needles reside in the card placed within the inserter handle.

The inserter, with the enclosed anchor, et al., delivers the product to the site. The inserter is composed of a plastic body (with an anchor release mechanism) and a stainless steel tube with a stainless steel shaft for anchor deployment. 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 only and sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the MTF Allograft Anchor, focusing on acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Design Input Requirements)	Reported Device Performance
Strength (Anchor Insertion & Fixation)	Met design input requirements for strength.
Dimensions	Within design requirements.
Insertion Repeatability	Found to be acceptable.
Pullout Values for Fixation Strength	Exceeded those of metal and polymeric devices used for similar types of fixation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the biomechanical testing (test set). The data provenance is also not specified; it is assumed to be internal testing conducted by the manufacturer, Musculoskeletal Transplant Foundation (MTF).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The study described is biomechanical testing, not a clinical study involving experts establishing ground truth from patient data.

4. Adjudication Method

Not applicable. The study is a biomechanical test, not a clinical study requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text describes a biomechanical study, not a clinical study involving human readers or comparative effectiveness with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical medical device (an anchor), not an algorithm or AI-driven system. The "standalone" performance here refers to the device's inherent mechanical properties.

7. Type of Ground Truth Used

The ground truth for this device's performance is based on engineering and biomechanical measurements against predefined design input requirements. This includes metrics like strength, dimensions, insertion repeatability, and pullout force.

8. Sample Size for the Training Set

Not applicable. This is a biomechanical test of a physical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device in this context. The "ground truth" for the device's performance was established by the design input requirements of the manufacturer and validated through the described biomechanical tests.

Summary

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K042038

DEC 2 3 2004

SUMMARY OF SAFETY AND EFFECTIVENESS 3.

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

Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourfdaconsultant.com

Tel: (301) 279-2899 Fax: (301) 294-0126

D. DATE OF PREPARATION OF THIS SUMMARY: December 21, 2004
MTF™ Allograft Anchor E. PROPRIETARY (TRADE) NAME:

F. COMMON NAME: Bone anchor

G. CLASSIFICATION NAME: Nonabsorbable Poly(ethylene Terepthalate) Surgical Suture
H. REGULATION NUMBER: 21 CFR 878.5000

I. PROPOSED REGULATORY CLASS: Class II

J. DEVICE PRODUCT CODE: GAT

K. PANEL CODE : 87 OR Orthopedic

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K042038 page 2/2

L. DESCRIPTION OF DEVICE

M. INDICATIONS FOR USE

The Allograft Anchor is intended for use in soft tissue approximation and/or ligation in orthopaedic procedures. ·

N. PREDICATE DEVICE

The MTF™ Allograft Anchor is substantially equivalent to The PhoenixTM 5.0 Allograft Anchor Kit (K011985), manufactured by Smith and Nephew.

O. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Both the MTF™ Allograft Anchor and The Phoenix 5.0 Allograft Anchor Kit have the same indications for use. MTFTM Allograft Anchor and its predicate are both made from machined human allograft bone derived from the tibia or femur recovered from deceased donors. Both MTFTM Allograft Anchor and its predicate require implantation into bone through use of an attached insertion device. The Smith and Nephew and MTFTM Allograft Anchor use USP Size Number 2 Braided Polyester Sutures.

P. SUMMARY OF STUDIES

Biomechanical testing of the MTF™ Allograft Anchor was performed to investigate whether the anchor meets design requirements. The conclusion of the anchor insertion and fixation test confirmed that the MTFTM Allograft Anchor meets design input requirements for strength. The tests also confirmed that the MTF™ Allograft 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEC 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Musculoskeletal Transplant Foundation c/o Mr. Norman F. Estrin, Ph.D., RAC Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K042038

Trade/Device Name: Allograft Anchor Regulation Number: 21 CFR 878.5000 Regulation Name: Synthetic non-absorbable PET suture Regulatory Class: II Product Code: GAT Dated: December 1, 2004 Received: December 6, 2004

Dear Dr. Estrin:

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 - Mr. Norman F. Estrin, Ph.D., RAC

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) 276-0115. 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1_of_1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K042038

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Allograft Anchor is intended for use in soft tissue approximation and/or ligation in orthopaedic procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.