(168 days)
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
- intertrochanteric derotation and varus osteotomies (100° and . 110° plates)
- femoral neck and petrochanteric fractures (120° plates) .
- intertrochanteric valgus osteotomies (150° plates)
The Synthes (USA) Pediatric LCP Hip Plate System is available in 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 degree angles. The plates are designed with three conical locking screw holes located at the head in conjunction with 3 or 4 combination locked-compression screw holes at the shaft. The fixed angle construct is created by means of three standard locking screws inserted through the head of the plate. The shaft of the plate accepts locking or cortex screws, depending on the nature of the fracture or the quality of bone.
In addition, the plates are manufactured from 316L stainless steel and available both sterile and non-sterile.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary and corresponding FDA letter for the "Synthes (USA) Pediatric LCP Hip Plate System," which outlines the device description, intended use, and substantial equivalence to a predicate device. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot generate the requested table and information.
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MAR 1 2007
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3.0 510(k) Summary
Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 (610) 719-5000
Synthes (USA) Pediatric LCP Hip Plate System Device Name:
21 CFR 888.3030: Single/multiple component metallic bone Classification: fixation appliances and accessories
Synthes Angled Blade Plates Predicate Devices:
The Synthes (USA) Pediatric LCP Hip Plate System is available in Device Description: 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 degree angles. The plates are designed with three conical locking screw holes located at the head in conjunction with 3 or 4 combination locked-compression screw holes at the shaft. The fixed angle construct is created by means of three standard locking screws inserted through the head of the plate. The shaft of the plate accepts locking or cortex screws, depending on the nature of the fracture or the quality of bone.
In addition, the plates are manufactured from 316L stainless steel and available both sterile and non-sterile.
The Synthes (USA) Pediatric LCP Hip Plate System is intended for Intended Use: fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults. Specific intertrochanteric derotation and varus indications include: neck and osteotomies (100° and 110° plates), femoral petrochanteric fractures (120° plates), and intertrochanteric valgus osteotomies (150° plates).
Information presented supports substantial equivalence. Substantial Equivalence:
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Deborah Jackson, RAC Regulatory Affairs Specialist 1301 Goshen Pkwy West Chester, PA 19380
MAR 1 3 2007
Re: K062872
Trade/Device Name: Synthes (USA) Pediatric LCP Hip Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: March 02, 2007 Received: March 05, 2007
Dear Ms. Jackson:
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. Deborah Jackson, RAC
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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Brehm
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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Page 1 of 1
2.0 Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
KO62872
Synthes (USA) Pediatric LCP Hip Plate System
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
- intertrochanteric derotation and varus osteotomies (100° and . 110° plates)
- femoral neck and petrochanteric fractures (120° plates) .
- intertrochanteric valgus osteotomies (150° plates)
X Prescription Use (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)
Barbave Brichum
Division of General, Restorative, and Neurological Devices
510(k) Number K062872
§ 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.