MERETE 3.0 AND 3.5 MM LOCKING SCREWS

K081513 · Merete Medical GmbH · HWC · Jul 18, 2008 · Orthopedic

Device Facts

• Record ID: K081513
• Device Name: MERETE 3.0 AND 3.5 MM LOCKING SCREWS
• Applicant: Merete Medical GmbH
• Product Code: HWC · Orthopedic
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates 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

Fully threaded, self-tapping titanium (ASTM F-136) locking screws; 3.0 mm and 3.5 mm diameters; lengths 12-32 mm. Used with Merete locking plates to create fixed-angle constructs for bone fracture/osteotomy stabilization. Operated by surgeons in clinical settings. Screw-to-plate locking mechanism provides rigid fixation; benefits patients by maintaining reduction in small bones, including osteopenic bone.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: Titanium (ASTM F-136). Design: Fully threaded, self-tapping, locking head. Dimensions: 3.0 mm and 3.5 mm diameter; 12 mm to 32 mm lengths. Principle: Screw-to-plate locking mechanism for fixed-angle construction.

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, Hallux Valgus, and middle hand/foot bones, particularly in osteopenic bone.

Regulatory Classification

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.

Predicate Devices

• Synthes Small Fragment Locking Compression Plate (LCP) (K000684)
• Smith & Nephew Locking Bone Plate System (K033669)
• DARCO Locking Bone Plate System (K061808)
• Merete MetaFix Small Fragment Locking Bone Plate System (K050457)
• Merete BLP Small Fragment locking Bone Plate System (K063487)

Submission Summary (Full Text)

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#### Summary of Safety and Effectiveness 3

Kossis13 pg 1 of 2

| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102,<br>12247 Berlin, Germany | |
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| FDA Registration Number: | 3002949614 | JUL 1 8 2008 |
| Contact Person: | Jörg Mietzner<br>Merete Medical, Inc.<br>49 Purchase Street<br>Rye, New York 10580<br>Phone: [phone] | |
| Device Name: | Merete 3.0 mm and 3.5 mm Locking Screws | |
| Device Classification: | 21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener. | |
| Product Code: | HWC | |
| Proposed Regulatory Class: | Class II | |

## Predicate Device:

- Synthes Small Fragment Locking Compression Plate (LCP) K000684 -
- Smith & Nephew Locking Bone Plate System K033669 -
- DARCO Locking Bone Plate System K061808 -
- Merete MetaFix Small Fragment Locking Bone Plate System K050457 -
- Merete BLP Small Fragment locking Bone Plate System K063487 -

## Device Description:

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 to 32 mm in 2 mm increments.

# Intended use:

The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates 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.

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# Technological Characteristics:

K051513 pg 2 of 2

The Merete 3.0 mm and 3.5 mm Locking Screws are similar to the screws of the legally marketed predicate devices listed above in that they share similar indications for use, are similar and incorporate similar technological manufactured from 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2008

Merete Medical, Inc. % Mr. Jörg Mietzner 49 Purchase Street Rye, NY 10580

Re: K081513 Trade/Device Name: Merete 3.0 mm and 3.5 mm Locking Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 30, 2008 Received: May 30, 2008

Dear Mr. Mietzner:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Jörg Mietzner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use 2

# Indications for Use

510(k) Number (if known): KOS | 5 | 3

Device Name: Merete 3.0 mm and 3.5 mm Locking Screws

Indications for Use:

The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |

Division of General, Restorative,
and Neurological DevicesMerete Medical GmbH
510(k) Number K081513