SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)

K092609 · Synthes (Usa) · HRS · Nov 17, 2009 · Orthopedic

Device Facts

• Record ID: K092609
• Device Name: SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Device Story

Metallic bone fixation system consisting of stainless steel or titanium curved narrow and broad plates; features combination of Dynamic Compression Plate (DCP) holes and locking screw holes. Used by orthopedic surgeons in clinical settings for internal fixation of fractures, osteotomies, and non-unions. Plates accept various cortex, cancellous, and locking screws to stabilize bone segments. Provides mechanical support to facilitate bone healing; particularly suited for osteopenic bone. Device is implanted surgically.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone plates (stainless steel or titanium). Features DCP holes combined with locking screw holes. Dimensions: 3.5 mm and 4.5 mm sizes. Mechanical fixation via cortex, cancellous, and locking screws. Non-electronic, mechanical device.

Indications for Use

Indicated for adult and pediatric patients requiring fixation of fractures, osteotomies, and non-unions/malunions of long bones (clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, fibula, femur). Includes use in osteopenic bone and periprosthetic fractures.

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 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807)

Submission Summary (Full Text)

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## 第一 K092609 11

3.0 510(k) Summary Page l Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 [phone] Sheri L. Musgnung Contact: NOV 1-7 2009 Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 [phone] FAX [phone] Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Device Name: Compression Plates (LCP) Class II, §888.3030 - Single/multiple component metallic bone Classification: fixation appliances and accessories Synthes 3.5 mm and 4.5 mm Locking Compression Plate (LCP) Predicate Device: System with Expanded Indications (K082807) The Synthes Curved Narrow and Broad LCP Plates are available in Device Description: stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws. The Synthes 3.5mm Curved Narrow and Broad LCP Plates are Intended Use: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. Information presented supports substantial equivalence. Substantial Equivalence:

Carana

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Synthes (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

NOV 1 7 2009

Re: K092609

Trade/Device Name: Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP)

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: HRS, HWC Dated: August 24, 2009 Received: August 25, 2009

Dear Ms. Musgnung:

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 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.

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Page 2 - Ms. Sheri L. Musgnung

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jonetta D

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

1502609 Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad

Locking Compression Plates (LCP)

Indications for Use:

The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients.

The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients.

The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Prescription Use X (Per 21 CFR 801.109)

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)

Mark Melkerer (Division Sign-Off Division of Surgical Orthopedic, and Restorative Devices

W

510(k) Number K092609

C.0000.4