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.
1. Avascular necrosis of the femoral head.
1. Acute traumatic facture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
The Porocoat® Prodigy™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

Device Description

The hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome-molybdenum alloy bead porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region of all stems and a modified geometric cut-out area on the medial aspect of the mid portion of the stem of larger-sized prostheses. The stem is designed to be used with AML reamers and broaches and now has been modified to be used with the Excel®/AML impactor. The design utilizes an anteverted neck with a taper for attachment of femoral ball heads. Cobalt-chromium-molybdenum alloy and aluminum ceramic femoral ball heads are intended to be used with the Prodigy Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty in combination with a porous coated metal backed acetabular cup prosthesis that uses an ultra high molecular weight polyethylene bearing (UHMWPe) surface.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the Porocoat® Prodigy™ Hip Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a comprehensive clinical study with performance metrics. Therefore, many of the requested categories related to acceptance criteria and detailed study design are not present in this document.

Here's an breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

This document does not present a table of acceptance criteria and reported device performance. The submission relies on demonstrating substantial equivalence to previously cleared devices rather than meeting new, explicit performance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical study with a test set. There are no performance data from a "test set" presented in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no test set or ground truth established by experts in this type of submission for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a hip prosthesis, not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a hip prosthesis, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. There is no ground truth presented as part of a performance study in this document. The "truth" in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not a machine learning device or study.

9. How the ground truth for the training set was established:

Not applicable. No training set mentioned.

Summary of the document based on the provided text:

This 510(k) submission (K000207) by DePuy Orthopaedics, Inc. is for the Porocoat® Prodigy™ Hip Prosthesis. The primary aim of this submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices, specifically the Porocoat® Prodigy™ Hip Prosthesis (K931641) and the Vision AML® Hip Prosthesis (K953694).

The device is a total hip joint replacement prosthesis with a porous coating, intended to increase patient mobility and reduce pain by replacing damaged hip joint articulation.

The argument for substantial equivalence is based on:

The fundamental scientific technologies of the Prodigy Hip Prosthesis having not changed from the cleared Prodigy Hip Prosthesis system (K931641) and Vision AML Hip System (K953694).
The intended use and indications for use remaining unchanged.
The device being manufactured from the same material (ASTM F-75 Cobalt Chromium Molybdenum alloy).
Minor design modifications being the only difference from the predicate device (K931641).
Conformance with design control procedures (21 CFR 820.30), similarities of design, commonly used materials, and identical sterilization processes.

The FDA reviewed the submission and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This allows the device to be marketed.

Summary

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

K 000207

510(k) Summary

Name of Sponsor:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) Contact:	Marcia J. ArentzSenior Regulatory AssociatePhone: (219) 371-4944FAX: (219) 371-4940
Trade Name:	Porocoat® Prodigy™ Hip Prosthesis
Common Name:	Total Hip Joint Replacement Prosthesis with porouscoating
Classification:	Class II Device per 21 CFR 888.3358:Hip joint metal/polymer/metal semi-constrainedporous coated uncemented prosthesis
Device Product Code:	Code: 87LPH Prosthesis Hip Semi-constrained,Metal/Polymer, CementedNo performance standards have been establishedunder Section 514 of the Federal Food, Drug, andCosmetic Act for femoral hip stems.
Substantially Equivalent Device:	Porocoat® Prodigy™ Hip Prosthesis K931641Vision AML® Hip ProsthesisK953694
Device Descriptions:	The hip stem is manufactured from ASTM F-75Cobalt-Chromium-Molybdenum alloy and has asintered cobalt-chrome-molybdenum alloy beadporous coating (Porocoat®) applied to the stem. Theporous coating is applied to the entire stem with theexception of the tapered stem tip region of all stemsand a modified geometric cut-out area on the medialaspect of the mid portion of the stem of larger-sizedprostheses. The stem is designed to be used withAML reamers and broaches and now has beenmodified to be used with the Excel®/AML impactor.The design utilizes an anteverted neck with a taperfor attachment of femoral ball heads. Cobalt-chromium-molybdenum alloy and aluminum ceramicfemoral ball heads are intended to be used with theProdigy Hip prosthesis to provide the femoralprosthetic articular surface for the total hiparthroplasty in combination with a porous coated

00000000

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

510(k) Summary (continued)

metal backed acetabular cup prosthesis that uses an ultra high molecular weight polyethylene bearing (UHMWPe) surface.

Intended use: 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.
1. Avascular necrosis of the femoral head.
1. Acute traumatic facture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
న్. Certain cases of ankylosis.

The fundamental scientific technologies of the Prodigy Hip Prosthesis have not changed from the FDA cleared Prodigy Hip Prosthesis system (K931641) and the Vision AML Hip System (K953694). The intended use and indications for use of the Prodigy Hip Prosthesis have not changed from the FDA cleared Prodigy Hip Prosthesis system (K931641). The Prodigy hip stem is manufactured from ASTM F-75 Cobalt Chromium Molybdenum alloy as are the Prodigy hip stem cleared in K931641 and the Vision AML Hip System (K953694). With the exception of the minor design modifications, the Prodigy hip stem is identical to the Prodigy hip stem device cleared in K931641.

Based on conformance with the design control procedures requirements as specified in 21 CFR 820.30, similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use, DePuy believes that the Porocoat Prodigy Hip Prosthesis to be substantially equivalent to the FDA cleared Prodigy Hip Prosthesis system (K931641) and the Vision AML Hip System (K953694).

Substantial equivalence:

Indications for use:

000007

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

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

K000207 Re:

Trade Name: Porocoat® Prodigy™ Hip Prosthesis Regulatory Class: II Product Code: LPH Dated: January 17, 2000 Received: January 24, 2000

Dear Ms. Arentz:

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 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 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 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.

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

Page 2 -- Ms. Marcia J. Arentz

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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Nel R. P. Ogden

James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

(000)0 510(k) Number (if known):

Porocoat® Prodigy™ Hip Prosthesis Device Name:

Indications for Use:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid 1. arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head or neck. 3.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. ડ.

The Porocoat® Prodigy™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)

Nho br 320

Division of General Restorative Devices
510(k) Number K000207

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use

$\mu_b$

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.