MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM

K050457 · Merete Medical GmbH · KTT · Mar 14, 2005 · Orthopedic

Device Facts

• Record ID: K050457
• Device Name: MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM
• Applicant: Merete Medical GmbH
• Product Code: KTT · Orthopedic
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• 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.

Indications for Use

Indicated for adult and pediatric patients requiring small bone fracture fixation, including fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, and middle hand/foot bones, particularly in osteopenic bone.

Regulatory Classification

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)
• Smith & Nephew Locking Bone Plate System (K033669)

Submission Summary (Full Text)

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510(k) Submission - Merete MetaFix™ Small Fragment Locking Bone Plate System

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| 510(k) Submission - Merete MetaFix™ Small Fragment Locking Bone Plate System | K050457 |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102, 12247 Berlin<br>Germany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Jenik Radon,<br>269 West Seventy-First Street<br>New York, N.Y. 10023<br>Tel. [phone] Fax [phone] |
| Device Name: | Merete MetaFix Small Fragment Locking Bone Plate System |
| Device Classification: | 21 CFR 888.3030 Single/multiple component Metallic bone<br>fixation appliances and accessories and 888.3040 Smooth<br>/threaded metallic bone fixation fastener. |
| Product Code: | KTT |
| Proposed Regulatory Class: | Class II |
| Predicate Device: | • Synthes Small Fragment Locking Compression Plate (LCP)<br>K000684<br>• Smith & Nephew Locking Bone Plate System<br>K033669 |
| Description of Device: | The Merete MetaFix Small Fragment Locking Plate System<br>consists of profile T-Oblique plates, right or of various left, of<br>various sizes and 3.0 mm locking screws. The system is<br>available in titanium (ASTM F-136). Locking plates/screws<br>incorporate a screw-to-plate locking feature which creates a<br>locked, fixed angle construction to hold fracture or osteotomy<br>reduction. |
| Intended use: | The Merete MetaFix Small Fragment Locking Plate System is<br>used for adult and pediatric patients as indicated for small<br>bone fracture fixation. Indications for use include fixation of<br>fractures, osteotomies, non unions of the clavicle, scapula,<br>olecranon, radius, ulner, fibula, metacarpals, metatarsals,<br>Hallux Valgus osteotomy corrections, middle hand and<br>middle foot bones, particular in osteopenic bone. |
| Technological Characteristics: | The components of the Merete MetaFix Small<br>Fragment Locking Plate System are similar to legally<br>marketed predicate devices listed above in that they share<br>similar indications for use, are manufactured from similar<br>materials and incorporate similar technological<br>characteristics. |
| Potential Risks: | The risks associated with this device are the same as with any<br>metallic internal fixation device. These include but not<br>limited to the following: Delayed or nonunion which may<br>lead to breakage the implant. Bending or fracture of the<br>implant. Metal sensitivity, or allergic reaction to a foreign<br>body. Pain, discomfort, or abnormal sensation due to the<br>presence 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 [phone] or [phone] 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