(191 days)
Not Found
No
The device description and intended use are solely focused on the mechanical properties and application of bone screws for fracture fixation. There is no mention of any software, algorithms, or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is described as a system of screws, such as locking screws and compression screws, used for the fixation of fractures, osteotomies, and joint fusions. These are all therapeutic applications aimed at restoring function or repairing damaged bone structures.
No
This device is a collection of screws designed for the fixation of fractures, osteotomies, and joint fusions. Its purpose is to physically stabilize bone structures, not to identify or diagnose medical conditions.
No
The device description clearly details various types of metallic bone screws made of titanium, which are physical hardware components. The intended use also describes their application in fracture fixation, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly stated as "fixation of fractures" and related orthopedic procedures. This involves surgical implantation to physically stabilize bone.
- Device Description: The device is described as various types of bone screws made of titanium. These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a surgical implant.
The information provided consistently describes a device used for surgical intervention on the musculoskeletal system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for use include fixation of fractures. For specific screw indications please see below.
MetaFix™ LS Locking Screws
- · For adult and pediatric patients
- · In combination with Merete Locking Plates
- · Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
- · Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone
Merete® Cannulated PCS
- · For adult and pediatric patients
- · Fixation of fresh fractures
- · Revision procedures
- · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® CS Cortical Screws
- · For adult and pediatric patients
- · Fixation of fresh fractures
- · Revision procedures
- · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® Cannulated HCS
- · Fixation of fractures and reconstruction of various bones
- · Osteotomies in the foot (as Hallux Valgus) or hand
- · Athrodesis in hand, foot or ankle surgery
- · Fixation of bone fragments in long bones or small bone fractures
DuoThread™ Scarf Screws
- · Small bone fracture fixation
- · Fixation and stabilization of bones of the feet
- · Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy)
- · Fusion (MPG-Athrodesis)
- · Fixation of almost all common osteotomies of the first metatarsal
TwistCut™ Snap-Off Screws
- · Fixation of fractures and reconstruction of bones
- · Fixation of small bone fragments
- · Mono cortical fixation
- · Osteotomies (Weil-Osteotomy)
- · Fracture fixation in the foot and hand
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS
Device Description
MetaFix™ LS Locking Screws
The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm).
Merete® Cannulated PCS
The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.
Merete® CS Cortical Screws
The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket.
Merete® Cannulated HCS
The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm) to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket.
DuoThread™ Scarf Screws
The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.
TwistCut™ Snap-Off Screws
The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, hand, feet, wrist, ankles, fingers, toes, long bones.
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)
The differences in technological characteristics were evaluated by mechanical testing in accordance with ASTM F543 Standard specification and Test Methods for Metallic Bone Screws. Those tests included driving torque and torsional testing. All products have successfully passed the tests. All screws named in the device description have hereby been proven to be mechanically as good as or better than the 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.
K081513, K120787, K140069, K130400, K091798, K050924, K051323
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
§ 888.3040 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Merete Medical Incorporated Matthias Möllmann Official Correspondent 4 Crotty Lane-Suite 118 New York International Plaza New Windsor, New York 12553
Re: K152187
Trade/Device Name: MetaFix™ LS Locking Screws, Merete® Cannulated PCS, Merete® CS Cortical Screws, Merete® Cannulated HCS, DuoThread™ Scarf Screws, TwistCutTM Snap-Off Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: January 8, 2016 Received: January 11, 2016
Dear Mr. Möllmann:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152187
Device Name
MetaFix™ LS Locking Screws, Merete® Cannulated PCS, Merete® CS Cortical Screws, Merete® Cannulated HCS, DuoThread™ Scarf Screws, TwistCut™ Snap-Off Screws
Indications for Use (Describe)
Indications for use include fixation of fractures. For specific screw indications please see below.
MetaFixTM LS Locking Screws
- · For adult and pediatric patients
- · In combination with Merete Locking Plates
- · Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
- · Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone
Merete® Cannulated PCS
- · For adult and pediatric patients
- · Fixation of fresh fractures
- · Revision procedures
- · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® CS Cortical Screws
- · For adult and pediatric patients
- · Fixation of fresh fractures
- · Revision procedures
- · Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® Cannulated HCS
- · Fixation of fractures and reconstruction of various bones
- · Osteotomies in the foot (as Hallux Valgus) or hand
- · Athrodesis in hand, foot or ankle surgery
- · Fixation of bone fragments in long bones or small bone fractures
DuoThread™ Scarf Screws
- · Small bone fracture fixation
- · Fixation and stabilization of bones of the feet
- · Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy)
- · Fusion (MPG-Athrodesis)
- · Fixation of almost all common osteotomies of the first metatarsal
TwistCut™ Snap-Off Screws
- · Fixation of fractures and reconstruction of bones
- · Fixation of small bone fragments
- · Mono cortical fixation
- · Osteotomies (Weil-Osteotomy)
- · Fracture fixation in the foot and hand
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness Information
as required by 21 CFR 807.92 Date Prepared: 06th January 2016 Merete Medical GmbH Submitted by: Alt-Lankwitz 102 12247 Berlin, Germany Contact Person: Mathias Möllmann Merete Medical, Inc. 4 Crotty Lane – Suite 118 New York International Plaza New Windsor, NY 12553 Phone: 914 967 1532 MetaFix™ LS Locking Screws, Merete® Cannulated PCS, Merete Device Name: CS Cortical Screws, Merete Cannulated HCS, DuoThread™ Scarf Screws, TwistCut™ Snap-Off Screws Common Name: SCREW, FIXATION, BONE Smooth or threaded metallic bone fastener - 21 CFR 888.3040 Classification Names: Single/multiple component metallic bone fixation appliances and accessories – 21 CFR 888.3030 Device Product Code: HWC, HRS Proposed Regulatory Class: Class II
Legally marketed Devices to which substantial Equivalence is claimed:
| K081513 | Merete 3.0 and 3.5 mm Locking Screws |
|---|---|
| K120787 | Merete Locking Bone Plate System III |
| K140069 | Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated PCS 3.0 |
| K130400 | Meretec CS, Cortical Screws |
| K091798 | Merete Compression Screws |
| K050924 | Merete DuoThreadTM Bone Screw |
| K051323 | Merete Twistcut Snap-Off Bone Screw |
Device Description:
MetaFix™ LS Locking Screws
The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm).
Merete® Cannulated PCS
5
The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.
Merete® CS Cortical Screws
The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket.
Merete® Cannulated HCS
The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket.
DuoThread™ Scarf Screws
The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.
TwistCut™ Snap-Off Screws
The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).
Indications for Use
Indications for use include fixation of fractures. For specific screw indications please see below.
MetaFix™ LS Locking Screws
- . for adult and pediatric patients
- . in combination with Merete Locking Plates
- . Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
- . Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone
Merete® Cannulated PCS
- for adult and pediatric patients
- Fixation of fresh fractures
- Revision procedures
- Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® CS Cortical Screws
- for adult and pediatric patients
- . Fixation of fresh fractures
- Revision procedures ●
6
- Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers . toes
Merete® Cannulated HCS
- Fixation of fractures and reconstruction of various bones ●
- . Osteotomies in the foot (as Hallux Valgus) or hand
- Athrodesis in hand, foot or ankle surgery
- Fixation of bone fragments in long bones or small bone fractures
DuoThread™ Scarf Screws
- . Small bone fracture fixation
- . Fixation and stabilization of bones of the feet
- . Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing Wedge Osteotomy)
- . Fusion (MPG-Athrodesis)
- Fixation of almost all common osteotomies of the first metatarsal
TwistCut™ Snap-Off Screws
- Fixation of fractures and reconstruction of bones ●
- Fixation of small bone fragments
- . Mono cortical fixation
- Osteotomies (Weil-Osteotomy)
- . Fracture fixation in the foot and hand
Comparison of technological characteristics with the predicate devices:
The basic technological characteristics of the screws named in the device description are the same as used for the predicate devices. Those characteristics contain the diameter, length, thread, pitch, amount of cutting flutes and if applicable (depending on the screw type) cannula diameter. The titanium material is also the same as used for the predicate devices and is in accordance to the specification given in ASTM-F136.
Differences in technological characteristics, caused by a change in the screwdriver screw-head interface, were evaluated by mechanical testing in accordance with ASTM F543 Standard specification and Test Methods for Metallic Bone Screws. Those tests included driving torque and torsional testing. Since all other mechanical specifications are the same as used for the predicate devices, the screws are considered to fulfil all defined criteria according to ASTM F543.
Further the screws are in sterile packaging. The sterilization process was validated according to current standards as well as the packaging system to protect the screws and ensure them to remain sterile.
All products have successfully passed the tests. All screws named in the device description have hereby been proven to be mechanically as good as or better than the predicate devices.
Substantial Equivalence:
The MetaFix™ LS Locking Screws, Merete® Cannulated PCS, Merete® CS Cortical Screws, Merete® Cannulated HCS, DuoThread™ Scarf Screws and TwistCut™ Snap-Off Screws have passed all defined criteria and have performed as well or better than the predicate devices and are therefore considered substantially equivalent to the cleared predicate devices.