(48 days)
The Synthes 4.5 mm LCP Straight Reconstruction Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Synthes 4.5 mm LCP Straight Reconstruction Plates consist of a limited contact profile and have LCP holes. The LCP hole is a combination of Dynamic Compression (DCU) and conical threaded locking holes, which accept cortex, shaft, cancellous, and locking screws. The plates are manufactured in either stainless steel or titanium.
The provided text describes Synthes 4.5 mm LCP Straight Reconstruction Plates, and references its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) premarket notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the format requested.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
The text primarily includes:
- Device Name: Synthes 4.5 mm LCP Straight Reconstruction Plates
- Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
- Predicate Device: Synthes 3.5 mm LCP Straight Reconstruction Plates
- Device Description: Limited contact profile plates with LCP holes (combination of Dynamic Compression (DCU) and conical threaded locking holes) manufactured in stainless steel or titanium.
- Intended Use/Indications for Use: Fixation of fractures, osteotomies, and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
- Substantial Equivalence: Claimed and affirmed by the FDA.
- FDA Correspondence: Official letter from the FDA confirming substantial equivalence and allowing marketing.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads "K051986". The characters are written in black ink on a white background and have a slightly irregular, handwritten style.
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo. There is a horizontal line underneath the word.
SEP - 8 2005
3.0 510(k) Summary
Page ________ of _____ of __1
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
|---|---|
| Device Name: | Synthes 4.5 mm LCP Straight Reconstruction Plates |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories |
| Predicate Devices: | Synthes 3.5 mm LCP Straight Reconstruction Plates |
| Device Description: | Synthes 4.5 mm LCP Straight Reconstruction Plates consist of alimited contact profile and have LCP holes. The LCP hole is acombination of Dynamic Compression (DCU) and conicalthreaded locking holes, which accept cortex, shaft, cancellous, andlocking screws. The plates are manufactured in either stainlesssteel or titanium. |
| Intended Use: | The Synthes 4.5 mm LCP Straight Reconstruction Plates areintended for fixation of fractures, osteotomies and non-unions ofclavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distaltibia, fibula, particularly in osteopenic bone. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
:
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circle around the eagle.
SEP - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Sr. Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051986
Trade/Device Name: Synthes (USA) 4.5 mm LCP Straight Reconstruction Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 21, 2005 Received: July 22, 2005
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 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. Sheri L. Musgnung
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 yours,
Neil R.P. Dykstra
Mark N. Mollen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure :
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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 4.5 mm LCP Straight Reconstruction Plates
INDICATIONS FOR USE:
The Synthes 4.5 mm LCP Straight Reconstruction Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
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)
Nil R. Ogden for mxm
Ci. Ross
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K051986
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§ 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.