(257 days)
Not Found
No
The description focuses on the mechanical properties and materials of bone plates and screws, with no mention of AI or ML.
No.
The device is described as a system for fixation of bones, which aids in healing and reconstruction, rather than providing therapy in the sense of treating a disease or condition actively.
No
This device is a bone plate system used for fixation of fractures and reconstruction in small bones, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of metal alloys (plates, screws, K-Wires) and describes mechanical testing, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The provided information clearly describes a system of bone plates, screws, and K-wires designed for the surgical fixation of bones within the body. This is an implantable medical device used for structural support and healing.
The description and intended use are entirely focused on surgical procedures and the physical repair of bone fractures and deformities, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTY
Device Description
The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires.
Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, feet, wrist, ankles, fingers, and toes.
Indicated Patient Age Range
adult 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing:
- Dynamic 4-point bending fatigue test (per ASTM F382-2003 and ISO 9585) .
- Screw torsion test (per ASTM F543 and ISO 6475) .
- Engineering rationale .
All tests considered the worst case scenario for the system and were passed successfully.
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.
Merete MetaFixTM Small Fragment Locking Bone Plate System K050457, Merete Locking Bone Plate System K090063, Merete 3.0 and 3.5 mm Locking Screws K081513, Ascension Total Plate System K100502, SBI K-Wires K051605, Kirschner and Guide Wires K100736
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
510(k) Summary of Safety and Effectiveness Information
| Date prepared: | November 2, 2012 |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt Lankwitz 102 | |
| 12247 Berlin, Germany | |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Donna Coleman |
| Merete Medical, Inc. | |
| 4 Crotty Lane - Suite 118 | |
| New York International Plaza | |
| New Windsor, NY 12553 | |
| Phone. 914 967 1532 | |
| 510(k) No.: | K120787 |
| Device Name: | Merete Locking Bone Plate System III |
| Device Classification: | 21 CRF 888.3030 Single/multiple component metallic bone |
| fixation appliances and accessories (Plate, Fixation, Bone) | |
| 21 CFR 888.3040 Smooth or threaded metallic bone fixation | |
| fastener (Screw, Fixation, Bone; Pin, Fixation, Smooth) | |
| Product Codes: | HRS |
| HWC | |
| HTY | |
| Regulatory Class: | Class II |
NOV 27### . Predicate Devices:
- Merete MetaFixTM Small Fragment Locking Bone Plate System K050457 .
- Merete Locking Bone Plate System K090063 .
- Merete 3.0 and 3.5 mm Locking Screws K081513 .
- Ascension Total Plate System K100502 .
- SBI K-Wires K051605 .
- Kirschner and Guide Wires K100736 .
Device Description:
The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires.
Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).
Intended use:
The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.
(pa 1/2)
1
11207876pg 2127
Technological Characteristics:
The components of Merete Locking Bone Plate System III are similar to legally marketed predicate devices listed above in that they share similar indications of use, are manufactured from similar materials and incorporate similar technological characteristics.
Potential risks:
The risks associated with this device are the same as with any metallic internal fixation device. These include but not limited to the following: Delayed or nonunion which may lead to breakage of the implant. Bending or fracture of the implant, metal sensitivity, or allergic reaction to a foreign body. Pain, discomfort, or abnormal sensation due to the presence of the device.
Mechanical testing:
In order to demonstrate that the Merete Locking Bone Plate System III has the mechanical properties necessary to perform its intended use and that the device performs as well as or better than the predicate devices, Merete has conducted nonclinical mechanical testing. This includes:
- Dynamic 4-point bending fatigue test (per ASTM F382-2003 and ISO 9585) .
- Screw torsion test (per ASTM F543 and ISO 6475) .
- Engineering rationale .
All tests considered the worst case scenario for the system and were passed successfully.
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2012
Merete Medical GmbH % Merete Medical, Incorporated Ms. Donna Coleman 4 Crotty Lane - Suite 118 New York International Plaza New Windsor, New York 12553
Re: K120787
Trade/Device Name: Merete Locking Bone Plate System III Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, HTY Dated: September 25, 2012 Received: October 1, 2012
Dear Ms. Coleman:
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 – Ms. Donna Coleman
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/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 yours,
Ronald P. Jean for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. Indications for Use Statement
Indications for Use
K12078
510(k) Number (if known):
Device Name: Merete Locking Bone Plate System III
Indications for Use: The Merete Locking Bone Plate System
can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi
for (Division Sign-Off)
Division of Orthopedic Devices
2012.11.21 08:55:15 -05'00'