(74 days)
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The system consists of 3 mm rods, ranging in length from 60mm to 180mm, and 3 styles of rod connectors, classified as right, left, and neutral. The rods are secured to the connectors using a pin nut. Screws are used to secure the connectors to the bone.
The provided text is a 510(k) summary for the DePuy Motech PEAK 3mm Fixation Rod System. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, study methodologies, or performance metrics in the context of an AI-powered medical device or software.
Therefore, I cannot fulfill your request for the tables and information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document pertains to a physical bone fixation rod system, not a digital diagnostic or AI-driven system.
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Ka8 0368
Image /page/0/Picture/1 description: The image shows the logo for DePuy. The logo consists of a black circle followed by the word "DePuy" in a bold, sans-serif font. A registered trademark symbol is located to the right of the "y" in "DePuy."
700 Orthonaedic Drive
Narsaw, Indiana 46581-0988
510(k) SUMMARY OF SAFETY AND EFFECTIVENESSDePuy Inc.
APR 1 4 1998
| NAME OF FIRM: | DePuy Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988 | U.S.A.Telephone: + 1 (219) 267 8143Fax: + 1 (219) 267 7196 |
|---|---|---|
| 510(K) CONTACT: | Lynnette WhitakerManager, Clinical/Regulatory Affairs | |
| TRADE NAME: | DePuy Motech PEAK 3mm Fixation Rod System | |
| COMMON NAME: | Bone Fixation Rod | |
| CLASSIFICATION: | 888.3030 Single/multiple component metallic bone fixationappliance and accessories | |
| DEVICE PRODUCT CODE: | Product code: 87 HRS | |
| SUBSTANTIALLYEQUIVALENT DEVICES: | ACE 3.5 mm Reconstruction Plate |
INTENDED USE AND DEVICE DESCRIPTION:
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The system consists of 3 mm rods, ranging in length from 60mm to 180mm, and 3 styles of rod connectors, classified as right, left, and neutral. The rods are secured to the connectors using a pin nut. Screws are used to secure the connectors to the bone.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Motech PEAK 3mm Fixation Rod System is similar in material, design and intended use to the ACE 3.5 mm Reconstruction Plate. The systems are intended to treat fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus, using rigid fixation with bone screws to secure the fracture. Mechanical testing shows that in 4 point bending the rigidity, strength and stiffness of the DePuy Motech PEAK 3mm Fixation Rod System exceeds that of the ACE 3.5 mm Reconstruction Plate 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with the head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1998
Ms. Lynnette Whitaker Manager, Clinical and Regulatory Affairs DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K980368 Re: DePuy Motech PEAK™ 3mm Fixation Rod System Regulatory Class: II Product Code: HRS Dated: January 28, 1998 January 30, 1998 Received:
Dear Ms. Whitaker:
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 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 aqainst 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 - Ms. Lynnette Whitaker
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA assoring 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 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fa ce
M. Witten, Ph.D., M.D. Celia Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name DePuy Motech PEAK 3mm Fixation Rod System
Indications for Use:
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Concurrence of CDRH, Office of Device Evaluation
Stuton Rhodes
K980368 General Restorative Devices 510(k) Numbe
Prescription Use (Per 21 CFR 801.109)
Over-The Counter Use __________
000002
OR
§ 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.