MODIFICATION TO TRIDENT ALL POLY CUP by HOWMEDICA OSTEONICS CORP.

The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

Device Description

The subject Trident™ All Poly Cup is available in Crossfire™ UHMWPE in outer diameters of 40mm to 50mm in two millimeter increments and inner diameters of 22mm, 26mm, and 32mm. The predicate device is manufactured from standard Ultra High Molecular Weight Polyethylene while the subject devices are manufactured from Crossfire™ Ultra High Molecular Weight Polyethylene. Both materials conform to ASTM F-648.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Trident™ All Poly Cup), which focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It is not a study that provides acceptance criteria and performance data for a diagnostic device, which is what the prompt requests.

Therefore, the document does not contain the information needed to fill out the requested table and answer the questions about acceptance criteria, study design, expert involvement, and ground truth.

The document does not provide information on:

Acceptance criteria (quantitative metrics for device performance)
Reported device performance (e.g., sensitivity, specificity, accuracy)
Sample sizes for test sets or their data provenance
Number/qualifications of experts to establish ground truth
Adjudication methods
Multi-reader multi-case (MRMC) comparative effectiveness studies
Standalone performance studies
Type of ground truth used (e.g., pathology, outcomes)
Sample size for training sets
How ground truth for training set was established

The document's purpose is to outline the device modification (material change) and assert substantial equivalence to a legally marketed predicate, not to report on diagnostic performance studies based on acceptance criteria.

Summary

{0}------------------------------------------------

MAR 2 0 2001

KOL 0310

Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Trident™ All Poly Cup

Trident™All Poly Cup

Proprietary Name:

Common Name:

All Polyethylene Acetabular Cup

Classification Name and Reference:

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

Proposed Regulatory Class:

Device Product Code:

87 JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented

For Information contact:

Jennifer A. Daudelin, Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 934-4354 Fax: (201) 760-8435 Email: idaudelin@howost.com

This Special 510(k) submission is intended to address a material modification to the Trident™ All Poly Cup. The design, manufacturing methods, intended use, packaging and sterilization of the subject device are identical to those of predicate device. The predicate device was found substantially equivalent via the 510(k) process in 510(k) #K001956. The predicate and subject devices are polyethylene acetabular components that are intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. Like the predicate, this cup is designed to be cemented into the acetabulum.

{1}------------------------------------------------

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, which is a symbol of medicine, with three lines representing the branches of government. The caduceus is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2001

Ms. Elizabeth A. Staub Vice President Regulatory Affairs, Quality Assurance and Clinical Research Stryker Howmedica Osteonics 59 Route 17 Allendale, Pennsylvania 07401-1677

Re: K010310 Trade Name: Trident™ All Poly Cup Regulatory Class: II Product Codes: JDI Dated: March 8, 2001 Received: March 9, 2001

Dear Ms. Staub:

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 sumou in the energials, to regardent 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 Continue of the Act. The general controls provisions of the Act include requirements for provisions of the rea- The generals, 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.

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

{2}------------------------------------------------

Page 2 - Ms. Elizabeth A. Staub

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Marli N Mullens

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

{3}------------------------------------------------

K010310

Indications for Use

510(k) Number (if known): Device Name: Trident™ All Poly Cup Indications for Use:

for Mark M. Milken

್storative ices and Neurological

510(k) Number -

K0103/0

(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)

Over-The-Counter Use ------------

(Optional Format 1-2-96)

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.