(82 days)
The Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the Synthes Small Fragment LCP System.
The Synthes LCP Distal Tibia Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.
This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML device. Therefore, the provided document does not contain information related to acceptance criteria, study performance, sample sizes, ground truth, or any other metrics typically associated with the evaluation of AI/ML device performance.
The document states that the device, Synthes LCP Distal Tibia Plates, was found to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a previously cleared device. The type of information requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, etc.) is not applicable to a traditional 510(k) clearance process based on substantial equivalence for a physical medical implant.
Therefore, I cannot provide the requested information from the given text as it pertains to AI/ML device evaluation.
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Summary of Safety and Effectiveness Information 3.
1
DEC 1 92001
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes LCP Distal Tibia Plates |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes LCPDistal Tibia Plates to be substantially equivalent to other legallymarketed devices. |
| Device Description | The Synthes LCP Distal Tibia Plates are machined metallic plates thatoffer screw to plate locking designed for various fracture modes of thedistal end of the tibia and other small bones. |
| Indications | The Synthes Locking Compression Plate (LCP) System is intended forfixation of fractures, osteotomies, and non-unions of the clavicle,scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, andfibula, particularly in osteopenic bone. The Synthes LCP Distal TibiaPlates are intended for fixation of complex intra- and extra-articularfractures and osteotomies of the distal tibia and other small bones as apart of the Synthes Small Fragment LCP System. |
| Materials | Stainless Steel or Titanium |
CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Mr. Matthew M. Hull, RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K013248
Trade/Device Name: Synthes (USA) LCP Distal Tibia 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: September 25, 2001 Received: September 28, 2001
Dear Mr. Hull:
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 - Mr. Matthew Hull
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 premailed 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 and 11 you docure openine art 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Celia M. Witten, Ph.D., M.D. 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 Statement 2.
510(k) Number (if known):
Device Name:
Indications for Use:
013248
Synthes LCP Distal Tibia Plates
The Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and Is inconded for the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates in ostoopolie or fixation of complex intra- and extraarticular fractures and osteotomies of the distal tibia and other small bones as a part of the Synthes Small Fragment LCP System.
Division Sign-Off) Division of General, Restorative and Neurological Devices
$10(k) Number_KU132 48
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Synthes(USA) Synthes LCP Distal Tibia Plates 510(k) CONFIDENTIAL
§ 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.