The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Porous-coated ASR™ 300 Acetabular Cups are indicated for cementless application.

Device Description

The subject DePuy ASR™ 300 Acetabular Cup System is part of a modular system for use in total hip replacement. The acetabular cup is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface features a porous coating with the addition of a plece cup. The outer suring. The cups feature three spikes for adjunct fixation and are available in ten sizes. The subject device is identical in design to the acetabular cups available in the DEPuy ASR™ Modular Acetabular Cup System in K040627 on August 5, 2005 with the addition of spikes on the outer surface of the cup.

AI/ML Overview

This document describes a 510(k) premarket notification for the DePuy ASR™ 300 Acetabular Cup System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and performance data in the same way one would for a novel device requiring a PMA.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, reported device performance, specific study details (sample sizes, expert involvement, adjudication, MRMC, standalone performance), or the method for establishing ground truth for training or test sets.

Instead, the submission states:

Basis of Substantial Equivalence: The device is considered substantially equivalent to previously cleared devices (DePuy ASR™ Modular Acetabular Cup System (K040627), Pinnacle Acetabular System (K000306), and Porocoat Lunceford Acetabulum (K823145)) based on "similarities in design, material, fabrication and intended use/indications for use."
Safety and Effectiveness: "The subject device does not raise any new issues of safety or effectiveness."

This means that DePuy Orthopaedics, Inc. asserted that since their new device is substantially equivalent to already approved devices, detailed performance studies with pre-defined acceptance criteria were not necessary for FDA clearance under the 510(k) pathway. The FDA's letter confirms this, stating, "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..."

To answer your request directly based only on the provided text:

Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence rather than meeting specific performance criteria demonstrated by a new study.
Sample sizes used for the test set and the data provenance: Not applicable/provided. No new test set study data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No new test set study data is presented.
Adjudication method for the test set: Not applicable/provided. No new test set study data is presented.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done and is not mentioned. This part of the submission relies on substantial equivalence.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical acetabular cup system, not an AI algorithm.
The type of ground truth used: Not applicable/provided. No new test set or training set data is presented. The "ground truth" for this submission is the established performance and safety of the predicate devices.
The sample size for the training set: Not applicable/provided. This device is a physical acetabular cup system, not an AI algorithm that undergoes training.
How the ground truth for the training set was established: Not applicable/provided. This device is a physical acetabular cup system, not an AI algorithm.

Summary

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K073413 (pg. 1 of 2)

Section 5 – 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)

JAN 30 zujc

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
MANUFACTURER:	DePuy International LimitedSt. Anthony RoadLeeds, United Kingdom LS11 8DTEstablishment Registration Number: 8010379
510(K) CONTACT:	Dawn SinclairRegulatory Affairs AssociateTelephone: (574) 372-5023Facsimile: (574) 371-4987Electronic Mail: Dsincla3@dpyus.jnj.com
510(K) PREPARER:	Rebecca LennardIndependent ContractorElectronic Mail: RLennard@dpyus.jnj.com
DATE PREPARED:	October 29, 2007
PROPRIETARY NAME:	DePuy ASR™ 300 Acetabular Cup System
COMMON NAME:	Acetabular Cup Prosthesis
CLASSIFICATION:	Class III per 21 CFR 888.3330, Hip jointmetal/metal semi-constrained, with anuncemented acetabular component, prosthesis
DEVICE PRODUCT CODE:	87 KWA
SUBSTANTIALLY EQUIVALENTDEVICE:	DePuy ASR™ Modular Acetabular Cup System,K040627DePuy Pinnacle® Acetabular Cup System,K000306Porocoat Lunceford Acetabulum, K823145

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DEVICE DESCRIPTION:

The subject DePuy ASR™ 300 Acetabular Cup System is part of a modular system The subject Del uy ASIC - 300 Ticcaburan - o of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-The acclabular cup to cestgliou as a porous coating with the addition of a plece cup. The outer suring. The cups feature three spikes for adjunct fixation and are nyailable in ten sizes. The subject device is identical in design to the acefabrian cups
available in ten sizes. The subject device is identical in design to the ace available in the DEPuy ASR™ Modular Acetabular Cup System in K040627 on August 5, 2005 with the addition of spikes on the outer surface of the cup.

INDICATIONS AND INTENDED USE:

Indications:

The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, severe pain and disability atthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Porous-coated ASR™ 300 Acetabular Cups are indicated for cementless application.

Intended Use:

The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.

The DePuy ASR™ 300 Acetabular Cup System is compatible with ASR femoral components.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy ASR™ 300 Acetabular Cup System described in this submission is substantially equivalent to the previously cleared DePuy ASR™ Modular Acetabular Cup System (K040627), the Pinnacle Acetabular System (K000306) and the Porocoat Lunceford Acetabulum (K823145) based upon the similarities in design, material Eumoord I rocuration and intended use/indications for use. The subject device does not raise any new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JAN 30 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Associate 700 Orthopaedic Drive P.O. Box 988 Warsaw, IN 46581-0988

K073413 Trade/Device Name: DePuy ASR The Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA Dated: December 3, 2007 Received: January 4, 2008

Dear Ms. Sinclair:

Re:

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 - Ms. Dawn Sinclair

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 the reporting 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

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

510 (k) Number (if known): __ KO734 13

DePuy ASRTM 300 Acetabular Cup System Device Name:

Indications for Use:

Porous-coated ASR™ 300 Acetabular Cups are indicated for cementless application.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Charlane Baichur for msm
Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K073413

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.