(19 days)
Not Found
No
The summary describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a bone plate system used for fracture fixation, which is a structural support rather than a direct therapeutic intervention that treats or cures a disease.
No
The Merete MetaFix Small Fragment Locking Bone Plate System is described as a device used for fracture fixation, meaning it is an orthopedic implant and not a diagnostic tool.
No
The device description clearly states it consists of physical components: plates and screws made of titanium. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Merete MetaFix Small Fragment Locking Bone Plate System is a system of plates and screws designed to be surgically implanted to fix bone fractures and osteotomies. It is a physical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use is for "small bone fracture fixation," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Merete MetaFix Small Fragment Locking Bone Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Merete MetaFix Small Fragment Locking Plate System is used for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
Product codes
KTT
Device Description
The Merete MetaFix Small Fragment Locking Plate System consists of profile T-Oblique plates, right or of various left, of various sizes and 3.0 mm locking screws. The system is available in titanium (ASTM F-136). Locking plates/screws incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot 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)
Not Found
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
§ 888.3030 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) Submission - Merete MetaFix™ Small Fragment Locking Bone Plate System
. .
| 510(k) Submission - Merete MetaFix™ Small Fragment Locking Bone Plate System | K050457 |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt Lankwitz 102, 12247 Berlin | |
| Germany | |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Jenik Radon, |
| 269 West Seventy-First Street | |
| New York, N.Y. 10023 | |
| Tel. 212- 496-2700 Fax 212- 724-3393 | |
| Device Name: | Merete MetaFix Small Fragment Locking Bone Plate System |
| Device Classification: | 21 CFR 888.3030 Single/multiple component Metallic bone |
| fixation appliances and accessories and 888.3040 Smooth | |
| /threaded metallic bone fixation fastener. | |
| Product Code: | KTT |
| Proposed Regulatory Class: | Class II |
| Predicate Device: | • Synthes Small Fragment Locking Compression Plate (LCP) |
| K000684 | |
| • Smith & Nephew Locking Bone Plate System | |
| K033669 | |
| Description of Device: | The Merete MetaFix Small Fragment Locking Plate System |
| consists of profile T-Oblique plates, right or of various left, of | |
| various sizes and 3.0 mm locking screws. The system is | |
| available in titanium (ASTM F-136). Locking plates/screws | |
| incorporate a screw-to-plate locking feature which creates a | |
| locked, fixed angle construction to hold fracture or osteotomy | |
| reduction. | |
| Intended use: | The Merete MetaFix Small Fragment Locking Plate System is |
| used for adult and pediatric patients as indicated for small | |
| bone fracture fixation. Indications for use include fixation of | |
| fractures, osteotomies, non unions of the clavicle, scapula, | |
| olecranon, radius, ulner, fibula, metacarpals, metatarsals, | |
| Hallux Valgus osteotomy corrections, middle hand and | |
| middle foot bones, particular in osteopenic bone. | |
| Technological Characteristics: | The components of the Merete MetaFix Small |
| Fragment Locking Plate System are similar to legally | |
| marketed predicate devices listed above in that they share | |
| similar indications for 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 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. |
1
3. Standards
The MetaFix-system is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2005
Merete Medical GMBH c/o Mr. Jenik Radon 269 West Seventy- First Street New York, New York 10023
Re: K050457
Trade/Device Name: Merete MetaFix Small Fragment Locking Bone Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: February 21, 2005 Received: February 23, 2005
Dear Mr. Radon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave levelewed your occirco. I substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predices marketed in interstate commerce prior to May 28, 1976, cherosure) to regarry manoledical Device Amendments, or to devices that have been reclassified in inc clance 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 approval of a promance approvat affect . The general controls provisions of the Act include the general connols provisions of the read 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 If your device is elassified (600 ac regulations affecting your device affecting your device can be found in the Sublot to sam a 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 requirements, merating, out neguirements 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.
3
Page 2 -- Mr. Jenik Radon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I list letter will anow you to ogen manential equivalence of your device to a legally marketed predicate nothication. The I DA imaing of substantaries arrathus, 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 If you desire specific advice tor your do not 100 . Also, please note the regulation entitled, "Misbranding by the Office of Comphance ut (210) 216 - 115 - 115 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 relerence to premainer nontroutent (on the Division of Small Manufacturers, International and your responsibilities under the rion the Driver (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Milliken
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K056457/A'
Indications for Use Merete MetaFix Small Fragment Locking Bone Plate System
510(k) Number (if known):_
Device Name: Merete MetaFix Small Fragment Locking Bone Plate
Indications For Use:
The Merete MetaFix Small Fragment Locking Bone Plate System is used for The Mercic wotan's onlairs as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the influications for aco intrado intradius, ulnar, fibula, metacarpals, Halllux Valgus Clavicle, Scapara, Shoranon, Tauland and middle foot bones, particular in osteopenic bone.
Prescription Use X (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)
Page 1 of 1
(Division Si)
Division of Ceneral, Restorative,
and Neurological Devices
510(k) Number K050457