The MEMOMETAL ANCHORAGE® Bone Plate Systems are indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, fingers and toes. The system may be used in both adults and pediatric patients.

Device Description

MEMOMETAL ANCHORAGE® Bone Plate Systems are single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made of biocompatible titanium. The Bone Plate Systems use either 3mm or 3,5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, lengths, number of plate holes and shape.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) Premarket Notification for the ANCHORAGE® Bone Plate System, primarily focused on establishing substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

Performance Data: The document explicitly states under "Performance data": "No clinical or non clinical tests were used in the claim of substantial equivalence." This means no studies were conducted by the manufacturer to demonstrate the device's performance against specific criteria, as they were relying on the equivalence to an already approved device.
Substantial Equivalence: The basis of this 510(k) submission is that the ANCHORAGE® Bone Plate System is "substantially equivalent" to the predicate device (K061808 DARCO locking bone plate system) in terms of intended use, indications for use, material, design, and function. This pathway allows a device to come to market without new clinical studies if it can be shown to be as safe and effective as a legally marketed predecessor.

Therefore, for each of your requested points, the answer based on this document is as follows:

Table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data are reported in this submission as no new tests were performed to support substantial equivalence.
Sample size used for the test set and the data provenance: Not applicable. No test set was used as no new studies were conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment was conducted as no new studies were performed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was performed.
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: Not applicable. This device is a bone plate system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone plate system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as no new studies were performed.
The sample size for the training set: Not applicable. This device is a physical medical device, not a machine learning model, and therefore had no "training set."
How the ground truth for the training set was established: Not applicable. Same reason as above.

Summary

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FEB - 6 2009

510k Premarket Notification ANCHORAGE® Bone Plate System MEMOMETAL TECHNOLOGIES

SECTION 5: 510(K) SUMMARY

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

Submitter	MEMOMETAL TECHNOLOGIESCampus de Ker Lann - Rue Blaise Pascal35170 BRUZ - FrancePhone: + 33 (0)2 99 05 59 69Fax :+ 33 (0)2 99 05 95 62
Contacts	Gilles AUDIC Quality ManagerBernard PRANDI General Managere-mail: gilles.audic@memometal.com bernard.prandi@memometal.com
Preparation date	11/17/2008
Trade Name	ANCHORAGE® Bone Plate System
Common Name	Bone Osteosynthesis Bone Plates System
Classification Name	Plate, Fixation, Bone
Legally marketed predicate devices	K061808 DARCO locking bone plate system
Description	MEMOMETAL ANCHORAGE® Bone Plate Systems are single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made of biocompatible titanium. The Bone Plate Systems use either 3mm or 3,5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, lengths, number of plate holes and shape.

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510k Premarket Notification
ANCHORAGE® Bone Plate System
MEMOMETAL TECHNOLOGIES

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Intended Use &Indication for use	The MEMOMETAL ANCHORAGE® Bone Plate Systems areindicated for stabilization and fixation of fresh fractures,revision procedures, joint fusion, and reconstruction of smallbones of the hand, feet, wrist and ankles, fingers and toes.The system may be used in both adults and pediatric patients.
Performance data	No clinical or non clinical tests were used in the claim ofsubstantial equivalence.
Substantial equivalence	The MEMOMETAL ANCHORAGE® Bone Plate Systems aresubstantially equivalent to their predicate devices DARCOlocking bone plate system in terms of intended use andindications for use, material, design (thickness, length,number of holes) and function. Any minor differences betweenthese two devices do not raise new questions of safety andeffectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2009

Memometal Technologies % Mr. Gilles Audic Quality Manager/Director Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France

Re: K083447

Trade/Device Name: ANCHORAGE® Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II

Product Code: HRS Dated: January 20, 2009 Received: January 23, 2009

Dear Mr. Audic:

We have reviewed vour 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 - Mr. Gilles Audic

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Mark H. Millman

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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510k Premarket Notification ANCHORAGE® Bone Plate System MEMOMETAL TECHNOLOGIES

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: MEMOMETAL ANCHORAGE® Bone Plate System Indications for Use:

The ANCHORAGE® Bone Plate System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, fingers and toes. The system may be used in both adults and pediatric patients.

Prescription Use✓	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division 文理: Division of General, Restorative, and Neurological Devices

510(k) Numbe

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.