SYNTHES LCP DISTAL FEMUR PLATES

K062564 · Synthes (Usa) · HRS · Oct 19, 2006 · Orthopedic

Device Facts

• Record ID: K062564
• Device Name: SYNTHES LCP DISTAL FEMUR PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.

Device Story

Synthes LCP Distal Femur Plates are metallic bone fixation implants designed for distal femur fracture stabilization. Part of the Locking Compression Plate (LCP) system, these plates feature a low-profile design available in left and right configurations. The shaft incorporates Dynamic Compression Plate (DCP) holes combined with locking screw holes, while the head contains threaded screw holes. Manufactured in stainless steel and titanium, they are provided in sterile or non-sterile versions. Used by orthopedic surgeons in clinical settings, the plates provide mechanical buttressing to support bone healing in complex fracture patterns. The device functions as an internal fixation system to maintain alignment and stability during the osteosynthesis process, potentially improving patient recovery outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plates; materials: stainless steel and titanium; design: low-profile, left/right versions; features: DCP holes, locking screw holes, threaded head holes; configuration: internal fixation; sterilization: sterile and non-sterile options.

Indications for Use

Indicated for patients with multifragmentary distal femur fractures, including supracondylar, intra-articular, extra-articular condylar, and periprosthetic fractures; also indicated for nonunions, malunions, and femoral osteotomies in normal or 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 LCP Curved Condylar Plates

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. There is a horizontal line below the word "SYNTHES".

3.0

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Ka2564

OCT 1 9 2006 __

| 510(k) Summary | Page 1 of 1 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes LCP Distal Femur Plates |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories. |
| Predicate Device: | Synthes LCP Curved Condylar Plates |
| Device Description: | Synthes LCP Distal Femur Plates are part of the Synthes Locking<br>Compression Plate (LCP) System. The plates have a low profile<br>design, are available in left and right versions with Dynamic<br>Compression Plate (DCP) holes combined with locking screw<br>holes in the shaft of the plate and threaded screw holes in the head<br>of the plate. The plates will be offered in stainless steel and<br>titanium and will be available in sterile and non-sterile versions. |
| Intended Use: | Synthes LCP Distal Femur Plates are intended for buttressing<br>multifragmentary distal femur fractures including: supracondylar,<br>intra-articular and extra-articular condylar, periprosthetic fractures<br>and fractures in normal or osteopenic bone, nonunions and<br>malunions, and osteotomies of the femur. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Image /page/1/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

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

Re: K062564

Trade/Device Name: Synthes LCP Distal Femur Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and . accessories Regulatory Class: Class II Product Code: HRS Dated: August 30, 2006 Received: August 31, 2006

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 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

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Page 2 - Ms. Sheri L. Musgnung

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.

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 vours,

Mark N' Melke

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a registered trademark symbol to the right of the word "SYNTHES". A horizontal line is present below the word.

Indications for Use

510(k) Number (if known):

Device Name:

2.0

Synthes LCP Distal Femur Plates

Indications for Use:

Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intraarticular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.

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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** L101564

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