(87 days)
Synthes LCP Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus. These plates can be applied to either the right or left humerus. The proximal portion of each plate has threaded holes that accept 3.5 mm or 2.7 mm screws. The distal portion of the plate has combination holes that allow the option of using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws to accomplish plate fixation. These plates will be offered as an addition to the Synthes Small Fragment LCP (formerly DCL) System.
This document is a 510(k) summary for the Synthes LCP Proximal Humerus Plate, submitted to the FDA in 2001. A 510(k) submission is for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving specific performance metrics against pre-defined acceptance criteria through a clinical study. Therefore, the information requested in the prompt, particularly regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details, is not typically found in this type of regulatory document.
The document focuses on:
- Device Description: The Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus, with threaded and combination holes for various screw types. They are an addition to the Synthes Small Fragment LCP System.
- Intended Use: Indicated for fractures, fracture-dislocations, osteotomies, and non-unions of the proximal humerus, especially in osteopenic bone.
- Materials: Available in Stainless Steel or Titanium.
- Predicate Devices: Synthes Small Fragment Dynamic Compression Locking (DCL) System and De Puy Ace Symmetry Proximal Humerus Plate.
- Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, it is not possible to answer the detailed questions about acceptance criteria, study methodologies, and performance metrics from the provided text because these elements are not part of a 510(k) substantial equivalence submission for this type of medical device at the time this document was generated.
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SEP - 6 2001
Summary of Safety and Effectiveness Information [510(k) Summary] 3.
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes LCP Proximal Humerus Plate |
| Regulation & Classification | Class II, §888.3030 - Plate, Fixation, Bone, Non-spinal, MetallicProduct code: NDF |
| Predicate Device(s) | - Synthes Small Fragment Dynamic Compression Locking (DCL)System- De Puy Ace Symmetry Proximal Humerus Plate |
| Device Description | The Synthes LCP Proximal Humerus Plates are designed to match theanatomy of the proximal humerus. These plates can be applied toeither the right or left humerus. The proximal portion of each plate hasthreaded holes that accept 3.5 mm or 2.7 mm screws. The distalportion of the plate has combination holes that allow the option ofusing 3.5 mm locking or cortex screws, or 4.0 mm cancellous screwsto accomplish plate fixation. These plates will be offered as anaddition to the Synthes Small Fragment LCP (formerly DCL) System. |
| Intended Use | Synthes LCP Proximal Humerus Plate is indicated for fractures,fracture dislocations, osteotomies, and non-unions of the proximalhumerus, particularly in osteopenic bone. |
| Material(s) | The LCP Proximal Humerus Plates will be available in eitherStainless Steel or Titanium versions as are the other plates in theSynthes Small Fragment LCP System. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2001
Mr. Matthew M. Hull, RAC Senior Regulatory Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K011815
Trade/Device Name: Synthes LCP Proximal Humerus Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTW
Dated: June 8. 2001 Received: June 11, 2001
Dear Mr. Hull:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Norman F. Estrin, Ph.D., RAC
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 6071 v 1011 onally, for questions on the promotion and advertising of your device, (2017) 594-1639. I readiness at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or Manufactor Internations met address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sis WC MD
For 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.
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications/ Contraindications:
Synthes LCP Proximal Humerus Plate
Koll 815
Synthes LCP Proximal Humerus Plate is indicated for ByIthes EOF Fracture dislocations, osteotomies, and fractures and the proximal humerus, particularly in osteopenic bone.
(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_
SL
Division of Oil
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011815
CONFIDENTIAL Synthes(USA) Synthes LCP Proximal Humerus Plates 510(k)
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.