(70 days)
The Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.
The technological characteristics of the Large Fragment Locking Plating System are the same as the predicate devices including design and material.
The provided text is a 510(k) summary for a medical device called the "Large Fragment Locking Plating System". It does not contain information about acceptance criteria, device performance, study details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. Performance data, in the sense of a clinical or analytical study with defined acceptance criteria and results, is not present.
Therefore, I cannot fulfill your request for the detailed information as it is not provided in the input text.
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Section 5 — 510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 328-3851Fax: (305) 270-1382 | NOV 07 2007 | ||||
|---|---|---|---|---|---|---|
| Contact Person: | Suzana Otaño, Sr. Regulatory Affairs Associate | |||||
| Date Prepared: | August 28, 2007 | |||||
| Proprietary Name: | Large Fragment Locking Plating System | |||||
| Common Name: | Plate, Fixation, Bone | |||||
| ClassificationName: | Single/multiple component metallic bone fixation appliancesand accessories (21 CFR § 888.3030) | |||||
| Predicate Devices: | Synthes | K000682 | Large Fragment DynamicCompression LockingSystem | |||
| DePuy | K060969 | POLYAX™ Locked PlatingSystem | ||||
| Intended Use: | The Large Fragment Locking Plating System is intended forfixation of various long bones, such as the humerus, femur andtibia. It is also for use in fixation of osteopenic bone andfixation and stabilization of non-unions, malunions andosteotomies. | |||||
| TechnologicalCharacteristics: | The technological characteristics of the Large FragmentLocking Plating System are the same as the predicate devicesincluding design and material. | |||||
| Summary ofSubstantialEquivalence: | The Large Fragment Locking Plating System is substantiallyequivalent to the currently marketed Synthes and DePuydevices. No new issues of safety or efficacy have been raised. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
NOV 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otano Sr. Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581
K072423 Re:
Trade/Device Name: Large Fragment Locking Plating System 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: October 8. 2007 Received: October 9, 2007
Dear Otano:
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 -- Suzana Otano
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Oalvarezm
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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SECTION 4 - INDICATIONS FOR USE STATEMENT
K072423 510(k) Number:
Large Fragment Locking Plating Device Name: System
Indications For Use: The Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarbaro buen
Division of General, Restorative. and Neur Jogical Devices
Page 1 of 1
510(k) Number K072423
Large Fragment Locking Plating System Traditional 510(k) DePuy Orthopaedics, Inc.
§ 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.