Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head 3. or neck.
Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
Certain cases of ankylosis. র.

The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Device Description

The Summit DuoFix™ Porous Hip prosthesis is a collarless, titanium, tapered femoral stem. The hip stem is manufactured from titanium (Ti-6Al-4V) and has a sintered commercially pure bead porous coating (Porocoat®) titanium applied to the stem with a thin layer of hydroxyapatite (HA) coating applied. The hip stem consists of 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options.

AI/ML Overview

The provided text is a 510(k) Summary for the DePuy Summit™ DuoFix™ Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this 510(k) summary.

Explanation:

510(k) Premarket Notification: This regulatory pathway is for medical devices that are "substantially equivalent" to a legally marketed predicate device. The primary goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to prove its performance against a predefined set of acceptance criteria in a new study.
Focus on Substantial Equivalence: The document explicitly states: "The Summit™ DuoFix™ Hip Prosthesis has the same intended use, is made from similar materials and has the same basic design as the predicate devices and is therefore substantially equivalent." This is the core argument.
"No performance standards have been established...": The document also notes under "Device Product Code" that "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems." This further emphasizes that there aren't FDA-mandated performance metrics that a study would be designed to meet.

To provide the requested details, one would typically need information from a full clinical trial report or a performance study that measures specific outcomes against predefined acceptance criteria, which is not part of this 510(k) submission.

Summary

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JUL 3 1 2001

Image /page/0/Picture/1 description: The image shows the DePuy logo, which is a black circle followed by the word "DePuy" in a stylized font. Below the word "DePuy" is the text "a Johnson & Johnson company" in a smaller font. At the top of the image is the number K011489.

510(k) Summary

DePuy Orthopaedics, Inc

700 Orthopaedic Drive 0 Box 988 Warsaw, Indiana 46581-0988 USA

Name of Sponsor:

510(k) Contact:

Trade Name:

Common Name:

Classification:

Device Product Code:

Substantially Equivalent Device:

Device Descriptions:

Marcia J. Arentz Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4940

DePuy Orthopaedics, Inc.

700 Orthopaedic Drive

Est. Reg. No. 1818910

Summit™ DuoFix™ Hip Prosthesis

Total Hip Joint Replacement Prosthesis with porous coating

700 Orthopaedic Drive

Class II Device per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis

Code: 87LPH Prosthesis Hip Semi-constrained, Metal/Polymer, Porous Uncemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.

Hip Stem K001991 DePuy Titan Porocoat Hip Stem Zimmer HGP Hip with HA/TCP coating K980711 HA/Porous Coating K001277 DePuy TriFlange Acetabular Cup

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510(k) Summary (continued)

Intended use:

Indications for use:

Total hip replacement is indicated in the following conditions:

Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head 3. or neck.
Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
ર. Certain cases of ankylosis.

The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Substantial equivalence:

The Summit™ DuoFix™ Hip Prosthesis has the same intended use, is made from similar materials and has the same basic design as the predicate devices and is therefore substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. The logo is black and white.

JUL 3 1 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K011489

Device Name: Summit DuoFix Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulatory Class: II Product Codes: LPH, MEH Dated: May 14, 2001 Received: May 15, 2001

Dear Ms. Arentz:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becaon 31 (x).) health and stantially equivalent (for the indications for use above and we nave dolorimined the actested predicate devices marketed in interstate commerce stated in the enclosure) to logally mazione of the Medical Device Amendments, or to devices that prox to May 20, 1970, the chiculation with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). "Tou may, alercrors, and the Act include requirements for annual provisions of the ret. "The general conanufacturing 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 (Fremarkst Approval), it may of sacreer of Sales of Federal Regulations, Title 21, Parts 800 to 895. alloomig your determination assumes compliance with the Current Good A substantially Oqurvaters 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 mspections, the Food and Drug rainingsult in regulatory action. In addition, FDA may publish comply with the GMI regarations your device in the Federal Register. Please note: this response to your premarks beforeming you submission does not affect any obligation you might response to your premariter associated 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

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Page 2 - Ms. Marcia J. Arentz

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,

Mmhluudr 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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510(k) Number (if known): _ Kol 1489)

Device Name: Summit™ DuoFix™ Hip Prosthesis

Indications for Use:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
1. Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. న్.

The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Concurrence of CDRH, Office of Device Evaluation

Bmotthellorpr can

(Division Sign-Off) Division of General, Restorative Over-The-Count Neurological Devices

510(k) Number KD 11489

OR Prescription Use (Per 21 CFR 801.109)

000003

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.