(108 days)
Not Found
No
The document describes a mechanical bone fastener made of a shape memory alloy and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is described as a permanent implant for bone fixation (fastener), which is a structural or mechanical support, not a therapeutic agent or device that delivers therapy.
No
The device is described as an implantable bone fastener for small bone reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "double X-shape K-Wire" made of a shape memory alloy, indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The MEMOMETAL INTRAMEDULLARY BONE FASTENER is a physical implantable device made of metal. It is used for bone fixation and reconstruction within the body.
- Intended Use: The intended use is for surgical procedures involving bone fusion and reconstruction, not for analyzing biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingers and toes and small bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) new device designs 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
ﻜﻢ ﺍﻟﺘﻲ ﺗﻜﻮﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ K112197
SECTION 5: 510(K) SUMMARY
NOV 1 7 2011
ﺮ ﺍﻟﻤ
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
Bernard PRANDI General Manager
e-mail: gilles.audic@memometal.com
bernard.prandi@memometal.com |
| 510K number | K070598 |
| Preparation date | 05/25/2011 |
| Trade Name | MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) new device designs |
| Common Name | INTRAMEDULLARY BONE FASTENER |
| Classification Name | Smooth or threaded metallic bone fastener |
| Legally marketed predicate devices | K070598 MEMOMETAL Intramedullary Bone Fastener Smart Toe & X-Fuse |
| Description | MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy. |
| Intended Use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion |
| Indication for use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion |
| Performance data | The MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) new device designs 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 INTRAMEDULLARY MEMORY BONE
FASTENER (SMART TOE & X-FUSE) new device designs are
substantially equivalent to their predicate device MEMOMETAL
INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE &
X-FUSE) (K070598) in terms of intended use and indications
for use, design and function and in term of material. Any
minor differences between these two devices do not raise
new questions of safety and effectiveness. |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 17 2011
Memometal Technologies % Mr. Gilles Audic Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France
Re: K112197
Trade/Device Name: Memometal Intramedullary Bone Fastener (Smart Toe & X-Fuse) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: October 20, 2011 Received: October 20, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
3
Page 2 - Mr. Gilles Audic
device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Eunice Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE & X-FUSE) .
Indications for Use:
The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
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)
Michael Owens for MXM
Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112197