MEMOMETAL BONE ANCHORS

K071941 · Memometal Technologies · HWC · Dec 4, 2007 · Orthopedic

Device Facts

• Record ID: K071941
• Device Name: MEMOMETAL BONE ANCHORS
• Applicant: Memometal Technologies
• Product Code: HWC · Orthopedic
• Decision Date: Dec 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MEMOMETAL Micro ARIM® is indicated for Hand: ligament reconstruction - Ankle: Midfoot reconstruction - Foot: Hallux Valgus reconstruction - Wrist: Scapholunate Ligament reconstruction - Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

Device Story

Single-use bone fixation anchor; manufactured from shape memory nickel-titanium alloy. Device introduced into bone in closed state; adopts opened position upon insertion to provide permanent fixation for ligament restoration. Used in orthopedic and urological procedures; operated by surgeons. Provides secure attachment point for sutures (USP 2-0 to 4-0) to facilitate tissue-to-bone repair. Benefits include secure ligament restoration and fixation for stress urinary incontinence.

Clinical Evidence

No clinical data. Conformity to ASTM F2063-05 for material properties provided.

Technological Characteristics

Shape memory nickel-titanium alloy; conforms to ASTM F2063-05. Single-use, permanent implant. Dimensions: 1mm thickness, 3.8mm length. Mechanical fixation via shape memory expansion in bone. Supplied with polyester or Fiberwire sutures.

Indications for Use

Indicated for patients requiring ligament or bone fixation in the hand, ankle (midfoot), foot (hallux valgus), wrist (scapholunate ligament), or pubis (bladder neck suspension for stress urinary incontinence).

Regulatory Classification

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.

Predicate Devices

• MINI QUICKANCHOR PLUS (MITEK) (K992487)

Submission Summary (Full Text)

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510k Premarket Notification Bone anchors MEMOMETAL TECHNOLOGIES

## Annexe 1bis

## SECTION 5: 510(K) SUMMARY

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

| Submitter | MEMOMETAL TECHNOLOGIES | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Campus de Ker Lann - Rue Blaise Pascal | |
| | 35170 BRUZ - France | |
| | Phone : + 33 (0)2 99 05 50 66 | |
| | Fax :+ 33 (0)2 99 05 95 62 | |
| Contacts | Gilles AUDIC Quality Manager | DEC 0 4 2007 |
| | Bernard PRANDI General Manager | |
| | e-mail: [e-mail] | |
| | [e-mail] | |
| Preparation date | 07/04/2007 | |
| Trade Name | MEMOMETAL Micro ARIM® anchor | |
| Common Name | Bone Anchor | |
| Classification Name | Smooth or threaded metallic bone fixation fastener. | |
| Legally marketed<br>predicate devices | K992487 MINI QUICKANCHOR PLUS (MITEK) | |
| Description | MEMOMETAL Micro ARIM® anchors are single-use bone | |
| | fixation appliances intended to be permanently implanted. | |
| | Micro ARIM® anchors made of shape memory nickel titanium<br>alloy. | |
| | MEMOMETAL Micro ARIM anchors can be used in 2 versions | |
| | with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed | |
| | : below: | |
| | Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester | |
| | suture (K012201) | |
| | Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire | |
| | suture (K041589) | |
| | | |
| | MEMOMETAL Micro ARIM® Anchors adopt an opened | |
| | position after introducing into bone which allows a permanent | |
| | fixation, thus supporting a secure ligament restoration. | |
| | | |
| Indication for use | The MEMOMETAL Micro ARIM® is indicated for<br>Hand: Ligament reconstruction<br>Ankle: Midfoot reconstruction<br>Foot: Hallux Valgus reconstruction<br>Wrist: Scapholunate Ligament reconstruction<br>Pubis: Fixation in the pubis for bladder neck suspension to<br>resolve stress urinary incontinence | |
| Performance data | THE MEMOMETAL Micro ARIM® conform to ASTM F2063-<br>05 Standard Specification for Wrought Nickel-Titanium Shape<br>Memory Alloys for Medical Devices and Surgical Implants. | |
| Substantial equivalence | THE MEMOMETAL Micro ARIM® are substantially equivalent<br>to their predicate devices MITEK MiniQUICKANCHOR Plus in<br>terms of intended use and indications for use, material, design<br>and function. Any minor differences between these two<br>devices do not raise new questions of safety and<br>effectiveness. | |

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510k Premarket Notification Bone anchors MEMOMETAL TECHNOLOGIES

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

DEC 0 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Memometal Technologies % Mr. Gilles Audic Quality Manager/ Director Campus de Ker Lann - Rue Blaise Pascal Bruz, France F35170

Re: K071941 Trade/Device Name: Memometal Micro ARIM® anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MBI Dated: November 15, 2007 Received: November 16, 2007

Dear Mr. Audic:

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. Gilles Audic

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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 N. Mulkerson

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 bone anchors MEMOMETAL TECHNOLOGIES

## INDICATIONS FOR USE

510(k) Number (if known): K071941
Device Name: MEMOMETAL MICRO ARIM® BONE ANCHOR
Indications for Use:

The MEMOMETAL Micro ARIM® is indicated for

- Hand: ligament reconstruction -
- Ankle: Midfoot reconstruction -
- Foot: Hallux Valgus reconstruction -
- Wrist: Scapholunate Ligament reconstruction -
- Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

Prescription Use Over-The-Counter Use _ > AND/OR (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)

Alush A. Mella

-11-Off Division S Division of General and Neurologic

510(k) Number K071941

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