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 osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
Certain cases of ankylosis.

The Titan Porocoat® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Device Description

The Titan Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip stem is manufactured from Titanium (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat®) applied to the stem. The hip stem consists of 11 body sizes ranging in diameter from 6mm to 18mm with each body size having two offset options.

AI/ML Overview

Based on the provided 510(k) summary for the Titan™ Porocoat® Hip Prosthesis, it is important to note that this document describes a medical device (a hip implant), not an AI/software device. Therefore, many of the typical acceptance criteria and study methodologies relevant to AI/software performance (e.g., sample size for test/training sets, ground truth by experts, MRMC studies, standalone performance) are not applicable or described in this type of submission.

510(k) submissions for medical devices like hip implants primarily focus on demonstrating substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria for diagnostic or algorithmic accuracy. The "study" here is the comparison to predicate devices and the design/materials of the new device itself.

However, I will extract the relevant information and indicate where typical AI/software device information is not available in these types of physical device submissions.

Acceptance Criteria and Device Performance (for a physical medical device)

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance/Comparison
Intended Use	To provide increased patient mobility and reduce pain by replacing damaged hip joint articulation in patients with sufficient sound bone to seat and support components.	"The Titan Porocoat Hip Prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent." This implies that its intended function is achieved in a comparable manner to already approved devices.
Indications for Use	1. Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery (various types). 5. Certain cases of ankylosis. 6. Indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.	"The Titan Porocoat Hip Prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent." The indications are explicitly stated as identical to the predicate devices. The hip stem is manufactured with a sintered commercially pure titanium bead porous coating (Porocoat®) specifically for cementless fixation and tissue ingrowth, aligning with the stated indication.
Design Characteristics	Collarless, titanium, tapered, press-fit femoral stem. Manufactured from Titanium (Ti-6Al-4V). Sintered commercially pure titanium bead porous coating (Porocoat®). 11 body sizes (6mm to 18mm) with two offset options per size.	The document describes the device's design and materials (titanium, porous coating), which are directly presented as its characteristics. The claim of "substantial equivalence" is based on these features being comparable to the predicate devices. For mechanical devices, performance is typically demonstrated through bench testing (e.g., fatigue, static strength, wear) to show that the new device meets established standards or performs comparably to the predicate, although these specific test results are not detailed in this high-level summary. The similarity in "basic design" to predicate devices (UNI-ROM Femoral Hip Stem K974331, Stability Hip Femoral Component K934457 with Porocoat, Vision AML Hip Prosthesis K953694) serves as the primary "performance" metric in a 510(k) for substantial equivalence.
Material	Titanium (Ti-6Al-4V) and sintered commercially pure titanium bead porous coating (Porocoat®).	Materials are explicitly stated. The choice of these materials is likely consistent with, or justified as equivalent to, the predicate devices.

Information Not Applicable or Not Provided for this Physical Medical Device 510(k) Summary:

Since this is a submission for a physical medical implant (hip prosthesis) and not an AI/software device, the following points as requested in your prompt are not applicable or not typically included in this type of 510(k) summary document. The "study" for such devices often involves bench testing, material characterization, and comparison to design principles of predicate devices, rather than clinical studies focused on algorithmic performance.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device like a hip implant. There isn't a "test set" of data in the sense of an algorithmic evaluation. Device performance is typically evaluated through mechanical testing, material analysis, and comparison to predicate device specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an implant isn't established by experts in the same way it would be for an image-based diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic or decision support device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For an implant, "ground truth" relates to its physical and biocompatible properties meeting specifications and performing as intended (e.g., mechanical strength, wear resistance, successful osseointegration). This is established through engineering and biological testing, not expert consensus on data cases.
The sample size for the training set: Not applicable. There is no AI model being trained.
How the ground truth for the training set was established: Not applicable.

Summary

510(k) Summary

Page 1

Name of Sponsor:
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910

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

Trade Name: Titan™ Porocoat® Hip Prosthesis

Common Name: Total Hip Joint Replacement Prosthesis with porous coating

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

Device Product Code: 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.

Substantially Equivalent Device:

UNI-ROM Femoral Hip Stem K974331
Stability Hip Femoral Component K934457 with Porocoat
Vision AML Hip Prosthesis K953694

Device Descriptions: The Titan Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip stem is manufactured from Titanium (Ti-6Al-4V) and has a sintered commercially pure titanium bead porous coating (Porocoat®) applied to the stem. The hip stem consists of 11 body sizes ranging in diameter from 6mm to 18mm with each body size having two offset options.

Page 2

510(k) Summary (continued)

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.

Indications for use: Total hip replacement is indicated in the following conditions:

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

Substantial equivalence: The Titan Porocoat Hip Prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent.

Page 3

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

AUG 25 2000

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K001991
Trade Name: Titan™ Porocoat® Hip Prosthesis
Regulatory Class: II
Product Code: LPH
Dated: June 26, 2000
Received: June 29, 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 control provisions of the Act. The general control 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.

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.

Page 4

Page 2 - Ms. Marcia J. Arentz

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,

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

Page 5

510(k) Number (if known): K001991

Device Name: Titan™ Porocoat® Hip Prosthesis

Indications for Use:

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

The Titan Porocoat® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) Division of General Restorative Devices

510(k) Number K001991

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)

Page 6

510(k) Number (if known): K001991

Device Name: Titan™ Porocoat® Hip Prosthesis

Indications for Use:

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

The Titan Porocoat® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices

510(k) Number K001991

Prescription Use ✓ OR Over-The-Counter Use
(Per 21 CFR 801.109)

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.