← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K050457 # MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM (K050457) _Merete Medical GmbH · KTT · Mar 14, 2005 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K050457 ## Device Facts - **Applicant:** Merete Medical GmbH - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Mar 14, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## 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. ## Device Story System consists of profile T-Oblique plates and 3.0 mm locking screws; titanium alloy construction. Locking mechanism creates fixed-angle construction to stabilize fracture or osteotomy reduction. Used by surgeons in clinical settings for internal bone fixation. Benefits include stable fixation in osteopenic bone. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Titanium alloy (Ti-6Al-4V) per ASTM F-136 and ISO 5832/3. Locking plate and screw system providing fixed-angle construction. Small fragment system. ## Regulatory 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. ## Predicate Devices - Synthes Small Fragment Locking Compression Plate (LCP) ([K000684](/device/K000684.md)) - Smith & Nephew Locking Bone Plate System ([K033669](/device/K033669.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K050457](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K050457) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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