(103 days)
No
The summary describes a mechanical bone fixation device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for fixation of bone fracture, bone reconstruction, or arthrodesis, which are therapeutic interventions.
No
Explanation: The device description clearly states that MEMOMETAL implants are used for "fixation of bone fracture, for bone reconstruction or arthrodesis," indicating they are therapeutic implants, not diagnostic tools. There is no mention of the device being used to identify, detect, or characterize a disease or condition.
No
The device description clearly states that the device is a "single-use bone fixation appliance intended to be permanently implanted," which describes a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of bone fracture, for bone reconstruction or arthrodesis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "single-use bone fixation appliances intended to be permanently implanted." This further reinforces its use in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to physically stabilize bone.
N/A
Intended Use / Indications for Use
The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
Product codes
HTY
Device Description
MEMOMETAL implants are single-use bone fixation appliances intended to be permanently implanted. MEMOMETAL implants are available in 2 different designs: - Snap-off pin, smooth with a stop and a sharp self drilling tip - Notched with a T-shaped head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engeneering rationale containing a comparison of mechanical properties of Ti-Fuse® and K-Snap® implants K100736 SMT Schilling Metalltechnik GMBH Kirschner and Guide wire under flexure loading (typical mechanical solicitation of the implants during the osteosynthesis period) has been performed. K-Snap® insertion testing in cortical bone has been performed to demonstrate that premature breakage doesn't occur.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES
Revision 3, 10/11/2010
SECTION 5: 510(K) SUMMARY
NOV - 3 2010
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 |
| Preparation date | 07/19/2010 |
| Trade Name | MEMOMETAL Implants (K-Snap® & Ti-Fuse®) |
| Common Name | MEMOMETAL implants |
| Classification Name | Smooth or threaded metallic bone fastener |
| Product code | HTY |
| Legally marketed predicate devices | K100736 SMT Schilling Metalltechnik GMBH Kirschner and
Guide wire
K022599 Newdeal K-Wire |
| Description | MEMOMETAL implants are single-use bone fixation
appliances intended to be permanently implanted.
MEMOMETAL implants are available in 2 different designs:
- Snap-off pin, smooth with a stop and a sharp self drilling tip
- Notched with a T-shaped head. |
| Intended Use | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are
indicated for fixation of bone fracture, for bone reconstruction
or arthrodesis in presence of appropriate immobilization. The
size of the implant should be adapted to the specific
indication. |
| Performance data | Engeneering rationale containing a comparison of mechanical |
| | properties of Ti-Fuse® and K-Snap® implants K100736 SMT |
| | Schilling Metalltechnik GMBH Kirschner and Guide wire under |
| | flexure loading (typical mechanical solicitation of the implants |
| | during the osteosynthesis period) has been performed. |
| | K-Snap® insertion testing in cortical bone has been |
| | performed to demonstrate that premature breakage doesn't |
| | occur. |
| Substantial equivalence | The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are |
| | substantially equivalent to their predicate (K100736) SMT |
| | Schilling Metalltechnik GMBH Kirschner and Guide wire and to |
| | Newdeal K-Wire (K022599) in terms of intended use, design |
| | and function. Any minor differences between these devices do |
| | not raise new questions of safety and effectiveness. |
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510k Premarket Notification Revision 3, 10/11/2010 + Osteosynthesis implants MEMOMETAL TECHNOLOGIES
2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MEMOMETAL TECHNOLOGIES % Mr. Gilles Audic Quality Manager Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France
NOV - 3 2010
Re: K102072
Trade/Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: HTY Dated: September 3, 2010 Received: September 7, 2010
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 device-related adverse events) (21 CFR 803); 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.
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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510k Premarket Notification Osteosynthesis implants MEMOMETAL TECHNOLOGIES
Revision 3, 10/11/2010
INDICATIONS FOR USE
NOV - 3 2010
02072 510(k) Number (if known):
Device Name: MEMOMETAL osteosynthesis implants (K-Snap® & Ti-Fuse®) Indications for Use:
The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
Prescription Use > (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souters for mxn
(Division Sign)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K102072
left
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