(77 days)
Not Found
No
The 510(k) summary describes a passive bone plate system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a bone plate system used for stabilization and fixation of fractures and is permanently implanted, which serves a structural and supportive role rather than directly curing or managing a disease or condition for therapeutic purposes in the way a therapeutic device would.
No
The device is a bone plate system used for stabilization and fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly states it is a bone plate system made of titanium, which is a hardware implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones." This describes a surgical implant used to treat physical injuries and conditions within the body.
- Device Description: The description details a "single use bone fixation appliance intended to be permanently implanted," made of titanium plates and screws. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and structural within the body.
N/A
Intended Use / Indications for 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.
Product codes
HRS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist and ankles, fingers and toes
Indicated Patient Age Range
adults and pediatric patients
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
No clinical or non clinical tests were used in the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
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
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 | 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. |
1
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:
:
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| 510k Premarket Notification | |
|---|---|
| ANCHORAGE® Bone Plate System | |
| MEMOMETAL TECHNOLOGIES |
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:
:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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100 million and the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the
.
.
| Intended Use &
Indication for 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. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | No clinical or non clinical tests were used in the claim of
substantial equivalence. |
| Substantial equivalence | The MEMOMETAL ANCHORAGE® Bone Plate Systems are
substantially equivalent to their predicate devices DARCO
locking bone plate system in terms of intended use and
indications for use, material, design (thickness, length,
number of holes) and function. Any minor differences between
these two devices do not raise new questions of safety and
effectiveness. |
:
:
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2
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
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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
| ✓ | 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