(249 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No.
This device is a bone plating system used for the fixation of fractures and osteotomies, rather than for therapeutic treatment.
No.
The device is a bone plating system for fixing fractures and osteotomies, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "single use bone fixation appliance intended to be permanently implanted" and describes physical components like plates, screws, and pegs made of titanium alloy. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures and osteotomies involving the distal radius." This is 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 is a physical implant used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The information clearly indicates that this is a surgical implant used for bone fixation, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
MEMOMETAL Navis® Bone Plating System is single use bone fixation appliances intended to be permanently implanted. They are designed with anatomical shape plates made of biocompatible titanium alloy. The Bone Plating System use 2.5 mm locking, unlocking screws and 1.8 mm smooth locking pegs. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different lengths, widths, number of plate holes, left and right shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
No clinical tests were used in the claim of substantial equivalence.
Mechanical characterization of plates including 3 points bending test have been performed to demonstrate equivalence between Memometal Navis® bone plate system (K101930) and Aptus® Medartis bone plate system (K051567). The test was processed in accordance with the ASTM F382-99 standard.
Additionally a characterization of the bending resistance of Memometal Navis® plates (K101930) and Medartis Aptus® plates (K051567) in bending loading conditions has been performed.
An engeneering rationale containing a comparison of mechanical properties bending strength between Memometal Navis® Pegs (K101930) and Trimed pegs (K060041) has been performed.
Mechanical characterization of pegs back out resistance on plates has been performed to demonstrate equivalence between Memometal Navis® bone plate system (K101930) and STRYKER variax® distal radius system (K050512 & K060514)
All these tests demonstrate substantial equivalence between the Navis® bone plating system and their predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K051567, K060041, K050512, K060514
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.
Not Found
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).
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
Image /page/0/Picture/0 description: The image shows the text "K101930" on the left side and "1/3" on the right side. The text is written in a handwritten style. The numbers and letters are all black against a white background.
MAR 1 5 2011
510k Premarket Notification Navis® Bone Plating 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 | 06/15/2010 |
| Trade Name | Memometal Navis® Bone Plating System |
| Common Name | Memometal Navis® Bone Plating System |
| Class | II |
| Product Code | HRS |
| HWC | |
| CFR section | 888.3030 |
| Classification Name | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Legally marketed | K051567 MEDARTIS, INC. APTUS® Titanium Fixation System |
| predicate devices | K060041 TRIMED Bone plates |
| K050512 & K060514 STRYKER variax® distal radius system | |
| Description | MEMOMETAL Navis® Bone Plating System is single use bone |
| fixation appliances intended to be permanently implanted. | |
| They are designed with anatomical shape plates made of | |
| biocompatible titanium alloy. The Bone Plating System use 2.5 | |
| mm locking, unlocking screws and 1.8 mm smooth locking | |
| pegs. The drill holes of the plates are aligned to assure the | |
| screws do not touch. The plates vary essentially through |
Page 11
1
| 510k Premarket Notification | |
|---|---|
| Navis® Bone Plating System | |
| MEMOMETAL TECHNOLOGIES |
| different lengths, widths, number of plate holes, left and | |
|---|---|
| right shapes. | |
| Intended Use & | |
| Indication for use | The Navis® radius Plate is indicated for the fixation of |
| fractures and osteotomies involving the distal radius. | |
| Performance data | No clinical tests were used in the claim of substantial |
| equivalence. | |
| Mechanical characterization of plates including 3 points | |
| bending test have been performed to demonstrate | |
| equivalence between Memometal Navis® bone plate system | |
| (K101930) and Aptus® Medartis bone plate system | |
| (K051567). The test was processed in accordance with the | |
| ASTM F382-99 standard. | |
| Additionally a characterization of the bending resistance of | |
| Memometal Navis® plates (K101930) and Medartis Aptus® | |
| plates (K051567) in bending loading conditions has been | |
| performed. | |
| An engeneering rationale containing a comparison of | |
| mechanical properties bending strength between Memometal | |
| Navis® Pegs (K101930) and Trimed pegs (K060041) has | |
| been performed. | |
| Mechanical characterization of pegs back out resistance on | |
| plates has been performed to demonstrate equivalence | |
| between Memometal Navis® bone plate system (K101930) | |
| and STRYKER variax® distal radius system (K050512 & | |
| K060514) | |
| All these tests demonstrate substantial equivalence between | |
| the Navis® bone plating system and their predicate devices. | |
| For this reason we didn't consider pre clinical data necessary. | |
| Substantial equivalence | The MEMOMETAL Navis® Bone Plating Systems are |
| substantially equivalent to their predicate MEDARTIS, INC. | |
| APTUS® Titanium Fixation System (K051567) for the plates | |
| and screws in terms of intended use and indications for use, | |
| material, design (thickness, length, number of holes) and | |
| function, and to TRIMED Bone plates (K060041) & STRYKER | |
| variax® distal radius system (K050512 & K060514) for Pegs | |
| in terms material, design (diameter, length), mechanical | |
| characteristics (back out and bending strength) and function. | |
| Any minor differences between these devices do not raise | |
| new questions of safety and effectiveness. |
·Page 12
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K 101930
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510k Premarket Notification Navis® Bone Plating System MEMOMETAL TECHNOLOGIES
3/3
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is made up of three curved lines, and the words are in a simple sans-serif font. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Memometal Technologies % Mr. Gilles Audic Campus de Ker Lann Rue Blaise Pascal 35170 BRUZ FRANCE
MAR 1 5 201
Re: K101930
Trade/Device Name: Memometal Navis Bone Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 1, 2011 Received: March 7, 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
4
Page 2 - Mr. Gilles Audic
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 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/ReportalProblem/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 yours.
AS.B.mh
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510k Premarket Notification | |
|---|---|
| Navis® Bone Plating System | |
| MEMOMETAL TECHNOLOGIES |
INDICATIONS FOR USE
510(k) Number (if known): _ K101930 Device Name: MEMOMETAL Navis® Bone Plating System Indications for Use:
- The Navis® radius Plate is indicated for the fixation of fractures and osteotomies involving the distal radius.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | ✓ |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (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)
for M. Melkerson
(Division Sign Off)
(Division Sign-Off)Y Division of Surgical, Orthopedic, and Restorative Devices
K101930
510(k) Number