(49 days)
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.
Synthes LCP Distal Femur Plates are part of the Synthes Locking Compression Plate (LCP) System. The plates have a low profile design, are available in left and right versions with Dynamic Compression Plate (DCP) holes combined with locking screw holes in the shaft of the plate and threaded screw holes in the head of the plate. The plates will be offered in stainless steel and titanium and will be available in sterile and non-sterile versions.
This 510(k) summary for the Synthes LCP Distal Femur Plates does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document describes the device, its intended use, and states that information presented supports substantial equivalence to a predicate device. This is typical for a 510(k) submission, where the primary goal is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical study data with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as they are not present in the provided text.
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3.0
.
Ka2564
OCT 1 9 2006 __
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 |
| Device Name: | Synthes LCP Distal Femur Plates |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories. |
| Predicate Device: | Synthes LCP Curved Condylar Plates |
| Device Description: | Synthes LCP Distal Femur Plates are part of the Synthes LockingCompression Plate (LCP) System. The plates have a low profiledesign, are available in left and right versions with DynamicCompression Plate (DCP) holes combined with locking screwholes in the shaft of the plate and threaded screw holes in the headof the plate. The plates will be offered in stainless steel andtitanium and will be available in sterile and non-sterile versions. |
| Intended Use: | Synthes LCP Distal Femur Plates are intended for buttressingmultifragmentary distal femur fractures including: supracondylar,intra-articular and extra-articular condylar, periprosthetic fracturesand fractures in normal or osteopenic bone, nonunions andmalunions, and osteotomies of the femur. |
| SubstantialEquivalence: | 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 (240) 276-0210 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 (800) 638-2041 or (240) 276-3150 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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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
000004
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.