MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

K083447 · Memometal Technologies · HRS · Feb 6, 2009 · Orthopedic

Device Facts

• Record ID: K083447
• Device Name: MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
• Applicant: Memometal Technologies
• Product Code: HRS · Orthopedic
• Decision Date: Feb 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

The ANCHORAGE® Bone Plate System consists of titanium bone plates and 3mm or 3.5mm screws used for orthopedic fixation. Plates feature varying curvatures, lengths, and hole configurations to accommodate small bone anatomy. Drill holes are aligned to prevent screw contact. The system is intended for permanent implantation in small bones of the extremities. It is used by surgeons in clinical settings to stabilize fractures, perform joint fusions, or reconstruct bones. The device provides mechanical support to facilitate bone healing.

Clinical Evidence

No clinical or non-clinical tests were used in the claim of substantial equivalence.

Technological Characteristics

Biocompatible titanium bone plates; 3mm or 3.5mm screws; various curvatures, lengths, and hole counts; single-use; permanent implant.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes in adult and pediatric patients.

Regulatory Classification

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.

Predicate Devices

• DARCO locking bone plate system (K061808)

Submission Summary (Full Text)

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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 TECHNOLOGIES<br>Campus de Ker Lann - Rue Blaise Pascal<br>35170 BRUZ - France<br>Phone: + 33 (0)2 99 05 59 69<br>Fax :+ 33 (0)2 99 05 95 62 |
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| Contacts | Gilles AUDIC Quality Manager<br>Bernard PRANDI General Manager<br>e-mail: [e-mail]<br>[e-mail] |
| 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 | |
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| ANCHORAGE® Bone Plate System | |
| MEMOMETAL TECHNOLOGIES | |

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| Intended Use &<br>Indication for use | The MEMOMETAL ANCHORAGE® Bone Plate Systems are<br>indicated for stabilization and fixation of fresh fractures,<br>revision procedures, joint fusion, and reconstruction of small<br>bones of the hand, feet, wrist and ankles, fingers and toes.<br>The system may be used in both adults and pediatric patients. |
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| Performance data | No clinical or non clinical tests were used in the claim of<br>substantial equivalence. |
| Substantial equivalence | The MEMOMETAL ANCHORAGE® Bone Plate Systems are<br>substantially equivalent to their predicate devices DARCO<br>locking bone plate system in terms of intended use and<br>indications for use, material, design (thickness, length,<br>number of holes) and function. Any minor differences between<br>these two devices do not raise new questions of safety and<br>effectiveness. |

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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 [phone]. 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 [phone] or [phone] 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<br><span style="text-align: center;">✓</span> | 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