MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE

K063487 · Merete Medical GmbH · KTT · Jan 22, 2007 · Orthopedic

Device Facts

• Record ID: K063487
• Device Name: MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
• Applicant: Merete Medical GmbH
• Product Code: KTT · Orthopedic
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Merete BLP™ 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.

Device Story

System consists of anatomically shaped U-oblique plates (33, 35, 37 mm) and 3.0 mm locking screws; titanium alloy construction. Operates via screw-to-plate locking mechanism creating fixed-angle construction to stabilize fractures or osteotomies. Used by surgeons in clinical settings for internal bone fixation. Provides mechanical stability to bone segments; facilitates healing in small bones, including osteopenic bone. Benefits include rigid fixation and reduction maintenance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F-136 and ISO 5832/3. Fixed-angle locking screw-to-plate mechanism. Anatomically shaped U-oblique plates in 33, 35, and 37 mm lengths. Mechanical fixation device.

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, middle hand/foot bones, and Hallux Valgus corrections; specifically indicated for 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)
• Merete MetaFix™ Small Fragment Locking Bone Plate (K050457)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness 3

K063487

| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102,<br>12247 Berlin, Germany |
|---------------|-------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------|

JAN 2 2 7007

FDA Registration Number: 3002949614

- Contact Person: Donna Coleman Merete Medical, Inc. 49 Purchase Street Rye, New York 10580 Phone: [phone]
Merete BLP™ Small Fragment Locking Bone Plate Device Name:

CFR 888.3030 Single/multiple component Device Classification: 21 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 -
- Merete MetaFix™ Small Fragment Locking Bone Plate K050457 -

# Device Description:

The Merete BLP™ Small Fragment Locking Bone Plate System consists of anatomically shaped U-oblique plates, right or left in the length of 33, 35 and 37 mm 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 BLP™ 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.

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### Technological Characteristics:

The components of the Merete BLP™ Small Fragment Locking Bone 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.

#### র্ব Standards

The Merete BLP™ Small Fragment Locking Bone Plate system is produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3.

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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 features a stylized eagle with its wings spread, clutching a caduceus in its talons. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merete Medical, Inc. % Ms. Donna Coleman 49 Purchase Street Rye, New York 10580

JAN 2 2 2007

Re: K063487

Trade/Device Name: Mecrete BLP"" Small Fragment Locking Bone Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 15, 2006 Received: November 17, 2006

Dear Ms. Coleman:

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 -- Ms. Donna Coleman

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 Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

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

Enclosure

cc: HFZ-401 DMC

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#### Indications for Use 2

# Indications for Use

510(k) Number (if known):

Device Name: Merete BLP™ Small Fragment Locking Bone Plate System

Indications for Use:

The Merete BLP™ 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.

| Prescription Use | <span></span> |
|-----------------------------|---------------|
| (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) n

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------|------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative, and Neurological Devices |
| Merete Medical GmbH | 510(November 2006) |
| | Page 5 of 22 |