The Articul/eze Femoral Heads are intended to be used with DePuy femoral hip stems with Articul/eze (12/14mm) male tapers in cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

Device Description

The subject Articul/eze Femoral Heads are Co-Cr-Mo alloy femoral heads available in: a 22.225mm diameter with +4 and +7 neck lengths: a 26mm diameter with +4, +7 and +10mm neck lengths and a 36mm diameter with -2, +1.5, +5, +8.5 and +12mm neck lengths. All of the Articul/eze taper femoral heads have an internal 5°43' taper which mates with the 5°40' external taper on DePuy Articul/eze taper femoral stems.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Articul/eze Femoral Heads) submitted to the FDA in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria and detailed statistical analysis of a device's performance against those criteria.

Therefore, the information required to fill out the table and answer the specific questions about acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document states that "DePuy believes that the subject Articul/eze Femoral Heads are substantially equivalent to the above listed predicate devices" based on "similarities of design, material and intended use," but it does not describe a performance study with defined acceptance criteria.

Therefore, an answer in the requested format cannot be generated from the given text.

Summary

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K980513

SUMMARY OF SAFETY AND EFFECTIVENESS

APR | 4 1998

NAME OF FIRM:	DePuy Inc.
	P.O. Box 988
	700 Orthopaedic Drive
	Warsaw, Indiana 46581-0988
510(k) CONTACT:	Cheryl Hastings
	Manager, Regulatory Submissions
TRADE NAME:	Articul/eze Femoral Heads
COMMON NAME:	Femoral Heads
CLASSIFICATIONS:	888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis
	888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
DEVICE PRODUCT CODES:	87 JDI and 87 LPH

SUBSTANTIALLY DePuy Focus Total Hip System (K883460) EQUIVALENT DEVICES: DePuy Zirconia Articul/eze Femoral Balls (K952088)

DEVICE DESCRIPTION AND INTENDED USE:

The Articul/eze Femoral Heads are intended to be used with DePuv femoral hip stems with Articul/eze male tapers in cemented or cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The listed substantially equivalent predicate device 510(k)s include Articul/eze taper cobalt-chrome alloy femoral heads in 28 and 32mm diameters and zirconia femoral heads in 26, 28 and 32mm diameters. The subject 22.225mm, 26mm and 36mm diameter Articul/eze taper cobalt-chrome femoral heads are being added to this line to give the surgeon a larger range of size and material options from which to select the best femoral head replacement for each patient. Based on similarities of design, material and intended use, DePuy believes that the subject Articul/eze Femoral Heads are substantially equivalent to the above listed predicate devices.

UOTHING

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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 an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1998

Ms. Cheryl Hastings Manager, Regulatory Submissions DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K980513 Re: Articul/eze Femoral Heads Trade Name: Regulatory Class: II Product Code: JDI and LPH February 6, 1998 Dated: February 10, 1998 Received:

Dear Ms. Hastings:

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 The general controls provisions of the Act 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Cheryl Hastings

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 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,

Stephen Rhodes

Celia M. Witten, Ph.D., M.D.
Director

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)_ K9 & S/3

Device Name DePuy Orthopaedics Articul/eze Femoral Heads

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Stato Rhodes

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Device

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

000002

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.