← Product Code [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR) · K070031 # MEMOMETAL MEMORY STAPLES (K070031) _Memometal Technologies · JDR · Mar 19, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K070031 ## Device Facts - **Applicant:** Memometal Technologies - **Product Code:** [JDR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR.md) - **Decision Date:** Mar 19, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. ## Device Story Memometal Memory Staples are single-use, permanently implanted bone fixation appliances. Available in bipodal or quadripodal configurations, these staples are constructed from shape memory nickel-titanium alloy. They are designed to provide compression across bone fragments or joints. Used by surgeons in clinical settings for orthopedic procedures involving the hand and foot, the staples function by utilizing the shape memory properties of the alloy to maintain fixation and compression at the surgical site, thereby facilitating bone healing and fusion. ## Clinical Evidence Bench testing only. The device conforms to ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples and ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. ## Technological Characteristics Bipodal or quadripodal bone fixation staples. Material: Nickel-titanium shape memory alloy. Standards: ASTM F564-02 (2006) and ASTM F2063-05. Single-use, permanent implant. ## Regulatory 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 - MEMORY STAPLE ([K964226](/device/K964226.md)) - MEMOGRAPH STAPLE ([K993714](/device/K993714.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "CONFIDENTIAL" in bold, uppercase letters. Above the word, there is a handwritten code "K070031/" in black ink. The word "CONFIDENTIAL" is partially obscured by a rectangular border. ## SECTION 5: 510(K) SUMMARY MAR 1 9 2007 ## 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 59 69
Fax :+ 33 (0)2 99 05 95 62 | |-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contacts | Gilles AUDIC Quality Manager
Bernard PRANDI General Manager
e-mail: gilles.audic@memometal.com
bernard.prandi@memometal.com | | Preparation date | December 20, 2006 | | Trade Name | MEMOMETAL MEMORY STAPLES (MEMOCLIP - EASY
CLIP - FOR FUSION) | | Common Name | MEMORY STAPLE | | Classification Name | Staple, Fixation, Bone | | Legally marketed predicate devices | K964226 MEMORY STAPLE (LANDOS - DEPUY Inc)
K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC) | | Description | MEMOMETAL MEMORY STAPLES are single-use bone
fixation appliances intended to be permanently implanted.
Memory staples are bipodal or quadripodal compression
staples made of shape memory nickel titanium alloy. | | Indication for use | The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and
FOR FUSION) are indicated for hand and foot bone
fragments osteotomy fixation and joint arthrodesis | | Performance data | THE MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and
FOR FUSION) conform to ASTM F564-02 (2006) Standard
Specification and Test Methods for Metallic Bone Staples and
to ASTM F2063-05 Standard Specification for Wrought
Nickel-Titanium Shape Memory Alloys for Medical Devices
and Surgical Implants. | | Substantial equivalence | THE MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and
FOR FUSION) are substantially equivalent to their predicate | | devices MEMORY STAPLE K964226 and MEMOGRAPH | | | STAPLE K993714 in terms of intended use and indications for | | | use, material, design and function. Any minor differences | | | between these two devices do not raise new questions of | | | safety and effectiveness. | | | | | {1}------------------------------------------------ 510k Premarket Notification Memory staples MEMOMETAL TECHNOLOGIES # CONFIDENTIAL : : . : . {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Memometal Technologies % Gilles Audic Quality Manager Rue Blaise Pascal Campus De Kerr Lann Bruz, France F35170 MAR 1 9 2007 Re: K070031 Trade/Device Name: Memometal Memory Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: December 28, 2006 Received: January 03, 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 {3}------------------------------------------------ ### 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 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. Sincerely yours, Harbauerfneems Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number (if known): Device Name: MEMOMETAL MEMORY STAPLES Indications for Use: The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. | and and the first of the first the first of the first of the first of the many of the many of the many of the many of the many of the many of the many of the many of the many
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) llara Buelum for MLM (Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices 510(k) Number K070037 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K070031](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDR/K070031) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com