(19 days)
The Merete MetaFix Small Fragment Locking Bone 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.
The Merete MetaFix Small Fragment Locking Plate System consists of profile T-Oblique plates, right or 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.
The provided text is a 510(k) summary for the Merete MetaFix™ Small Fragment Locking Bone Plate System. This type of submission is for medical devices that aim to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, or clinical outcome data) is not present in this document.
Instead, the submission focuses on comparing the new device's technological characteristics, materials, and intended use to existing predicate devices to show that it raises no new questions of safety or effectiveness.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
This document does not report specific acceptance criteria or device performance data in the way a clinical study or a performance test for a diagnostic device would. For orthopedic implants like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence based on material properties, mechanical testing (often referenced by standards), and similarity of design and indications for use to predicate devices.
The document states:
| Criterion Type | Substantial Equivalence Claim |
|---|---|
| Material Composition | "The MetaFix-system is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3." This indicates compliance with established material standards for biocompatibility and mechanical properties, similar to predicate devices. |
| 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." |
| Indications for Use | The stated indications for use (fixation of fractures, osteotomies, non-unions of specific bones, particularly in osteopenic bone, for adult and pediatric patients) are essentially identical to the scope of predicate devices. |
| Design/Function | The description "incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction" describes a common and accepted technological characteristic also found in predicate locking plate systems. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Applicable. This 510(k) submission does not describe a "test set" in the context of clinical data or AI model evaluation. It relies on a comparison to predicate devices and adherence to established material and manufacturing standards. There is no patient data or test data of that nature described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Applicable. As there is no test set in the sense of clinical or diagnostic data, there are no experts establishing ground truth for such a set within this submission. The "experts" involved would be the engineers and regulatory specialists who developed and documented the device, ensuring it met relevant standards and was comparable to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Applicable. There is no test set or adjudication method described for clinical outcomes or diagnostic accuracy.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not Applicable. This is an orthopedic implant, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" for demonstrating substantial equivalence primarily relies on:
- Established material standards: (ASTM F-136, ISO 5832/3 for Ti-6Al-4V).
- Mechanical performance data (implied): While not explicitly presented, the similarity to predicate devices implies that the mechanical properties (e.g., strength, stiffness, fatigue resistance) of this system would have been internally tested to ensure they meet performance benchmarks comparable to existing, safe, and effective devices in this class. These tests are typically conducted according to recognized ASTM or ISO standards for bone plates and screws.
- Historical clinical outcomes of predicate devices: The safety and effectiveness of the Merete system are inferred from the long-standing safe and effective use of its predicate devices with similar designs, materials, and intended uses.
8. The sample size for the training set:
Not Applicable. There is no "training set" in the context of AI or machine learning for this device.
9. How the ground truth for the training set was established:
Not Applicable. As there is no training set for AI, this question is not applicable.
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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 GmbHAlt Lankwitz 102, 12247 BerlinGermany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Jenik Radon,269 West Seventy-First StreetNew York, N.Y. 10023Tel. 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 bonefixation 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 SystemK033669 |
| Description of Device: | The Merete MetaFix Small Fragment Locking Plate Systemconsists of profile T-Oblique plates, right or of various left, ofvarious sizes and 3.0 mm locking screws. The system isavailable in titanium (ASTM F-136). Locking plates/screwsincorporate a screw-to-plate locking feature which creates alocked, fixed angle construction to hold fracture or osteotomyreduction. |
| Intended use: | The Merete MetaFix Small Fragment Locking Plate System isused for adult and pediatric patients as indicated for smallbone fracture fixation. Indications for use include fixation offractures, osteotomies, non unions of the clavicle, scapula,olecranon, radius, ulner, fibula, metacarpals, metatarsals,Hallux Valgus osteotomy corrections, middle hand andmiddle foot bones, particular in osteopenic bone. |
| Technological Characteristics: | The components of the Merete MetaFix SmallFragment Locking Plate System are similar to legallymarketed predicate devices listed above in that they sharesimilar indications for use, are manufactured from similarmaterials and incorporate similar technologicalcharacteristics. |
| Potential Risks: | The risks associated with this device are the same as with anymetallic internal fixation device. These include but notlimited to the following: Delayed or nonunion which maylead to breakage the implant. Bending or fracture of theimplant. Metal sensitivity, or allergic reaction to a foreignbody. Pain, discomfort, or abnormal sensation due to thepresence of the device. |
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3. Standards
The MetaFix-system is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3.
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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.
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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
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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
§ 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.