The DePuy Profile Femoral Hip with Porocoat prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

Device Description

The DePuy Profile® Hip with Porocoat® prosthesis is identical in design and materials to the DePuy Profile® Hip with Porocoat® prosthesis cleared by FDA for cemented use (K872776). The prosthesis is designed with an anatomical conformance to the medullary canal, proximal porous-coating, rounded distal taper, and 12/14 femoral neck taper which allows for the use of interchangeable modular femoral heads. The prosthesis is available in six sizes, each are available in right and left configurations.

AI/ML Overview

This 510(k) premarket notification is for a medical device, specifically a hip prosthesis. The acceptance criteria and supporting study details for such devices typically focus on demonstrating substantial equivalence to already legally marketed predicate devices, primarily through design, material, and intended use comparisons, as well as biocompatibility and mechanical testing. It's important to note that this submission does not describe a study involving an AI algorithm or performance metrics like sensitivity, specificity, or reader studies with human-in-the-loop. Instead, the "study" is a comparison and verification of physical device properties.

Here's a breakdown of the requested information based on the provided text, adapted for a medical device submission that is not an AI/software device:

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

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria are generally demonstrated by showing sameness or equivalence to established predicate devices in crucial aspects that ensure safety and effectiveness. The "performance" is the device meeting these equivalence criteria.

Acceptance Criterion	Reported Device Performance (DePuy Profile® Femoral Hip with Porocoat® - this submission)	Justification/Reference to Predicate Device
Intended Use	Uncemented (additional indication specified), or Cemented	Substantially Equivalent to:- DePuy Stability Hip (K934457) for uncemented use.- DePuy Profile® Femoral Hip with Porocoat® (K872776) for cemented use.
Stem Material	Ti-6Al-4V alloy, conforming to ASTM F-620	Identical to:- All listed predicate devices (K934457, K872776, K910156, K850055).
Proximal Surface Coating	Porocoat® Porous-coating	Identical/Similar to:- DePuy Stability Hip (K934457) and DePuy Profile® Porocoat® (K872776). Different from Hydroxyapatite (K910156) or None (K850055) but justified by equivalence to Porocoat® predicates.
Design (Anatomical)	Anatomical conformance to medullary canal, rounded distal taper	Identical to:- All listed predicate devices (K934457, K872776, K910156, K850055).
Modular Heads	Yes	Identical to:- All listed predicate devices (K934457, K872776, K910156, K850055).
Modular Taper	12/14mm	Identical to:- All listed predicate devices (K934457, K872776, K910156, K850055).
Manufacturing Process	Unchanged from previously cleared DePuy Profile® Hip with Porocoat® (K872776)	Identical to:- DePuy Profile® Hip with Porocoat® (K872776).

2. Sample Size for the Test Set and Data Provenance

Test Set Description: Not applicable in the conventional sense for an AI device. The "test set" here would refer to the characteristics and specifications of the device itself and its components.
Sample Size: This submission does not refer to sample sizes of patient data or clinical images for testing an algorithm. Instead, it would involve testing of physical device samples for mechanical properties, material composition, and coating adherence, but specific "sample sizes" for these tests are not detailed in this summary.
Data Provenance: Not applicable for an AI device. The provenance related to this device would be its manufacturing origin (DePuy Orthopaedics, Inc., Warsaw, Indiana, USA). The basis of substantial equivalence relies on existing FDA-cleared devices, implying their performance data (which is not detailed here) supports the equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as this is not an AI/software device requiring ground truth established by clinical experts for classification or diagnosis. The "ground truth" for a physical device is its adherence to material standards, design specifications, and mechanical performance, typically verified by engineers and material scientists.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/software device. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance. This submission does not involve an AI component.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI/software device.

7. Type of Ground Truth Used

Not applicable in the context of an AI device. For this physical device, the "ground truth" for its safety and effectiveness is established by:
- Material specifications: Conformance to ASTM F-620 for Ti-6Al-4V alloy.
- Design specifications: Conformance to established anatomical and modular head designs of predicate devices.
- Manufacturing process control: Ensuring the process is identical or equivalent to previously cleared devices.
- Intended use alignment: Matching the specified indications for use with predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/software device, so there is no "training set" in the machine learning sense. The "training" for such a device is the established design, manufacturing processes, and materials, which have been refined over multiple generations of products and backed by extensive engineering and clinical experience with predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set. The "ground truth" for the predicate devices was established through a combination of engineering design principles, material science, mechanical testing, biocompatibility testing, animal studies (if applicable), and post-market surveillance and clinical experience over time that led to their initial FDA clearance. This submission leverages the established safety and effectiveness profile of these predicates.

Summary of the "Study" for K984459:

The "study" presented in this 510(k) is a comparison-based substantial equivalence justification. It's not a clinical trial or performance study with patients, but rather a detailed analysis demonstrating that the new device, DePuy Profile® Femoral Hip with Porocoat®, is sufficiently similar in design, materials, and intended use to existing FDA-cleared predicate devices to be considered safe and effective for its expanded indication (uncemented use).

The submission relies on a table-based comparison of key attributes (Intended Use, Stem Material, Proximal Surface Coating, Design, Modular Heads, Modular Taper) against four predicate devices (K934457, K872776, K910156, K850055). The acceptance criteria are implicitly met when the device's attributes are demonstrated to be identical or sufficiently similar to those of the legally marketed predicate devices, thereby leveraging the predicate devices' established safety and effectiveness.

No AI components, algorithms, or associated performance metrics like sensitivity/specificity are mentioned or evaluated in this submission.

Summary

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K984459

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR OF THIS 510(K):	DePuy Orthopaedics, Inc.a Johnson & Johnson companyP.O. Box 988700 Orthopaedics DriveWarsaw, Indiana 46581-0988
510(K) CONTACT:	Sally FoustSr. Regulatory AssociateDePuy Orthopaedics, Inc.a Johnson & Johnson company(219) 372-7455; FAX (219) 267-7098
TRADE NAME:	DePuy Profile® Femoral Hip with Porocoat®
COMMON NAME:	Hip Device
CLASSIFICATION:	888.3358 Hip joint metal/polymer semi-constrainedporous coated uncemented prosthesis
DEVICE CODE:	87LPH
EQUIVALENT DEVICES:	DePuy Stability Hip System with Porocoat®(K934457) (Uncemented, K934457)DePuy Profile® Femoral Hip Prosthesis withPorocoat® (Cemented, K872776)DePuy Hydroxyapatite Coated Profile® Hip Stem(Press-Fit, K910156)DePuy Profile® Femoral Hip (Press-Fit, K850055)

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Profile® Femoral Hip with Porocoat® prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Profile® Hip with Porocoat® prosthesis is similar in design (proximal porous coating, anatomical, and modular heads), identical in material (Ti-6AI-4V alloy) and intended use (uncemented) to the previously cleared DePuy Stability Hip (K934457).

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With the exception of the additional intended use (uncemented), the DePuy Profile® Femoral Hip with Porocoat® prosthesis is identical in design, material (Ti-6AI-4V alloy) and intended use (cemented) to the previously cleared DePuy Profile® Femoral Hip with Porocoat® prosthesis (K872776). The material (Ti-6A1-4V alloy conforming to ASTM F-620), manufacturing process and design of the DePuy Profile® Hip with Porocoat® prosthesis, including stem diameters, location of the porous coating and characteristics of the porous coating will not be changed from those of the DePuy Profile® Hip with Porocoat® prosthesis previously cleared (K872776) by FDA.

The DePuy Profile® Hip with Porocoat® prosthesis is identical in material (Ti-6Al-4V alloy), similar in design (proximal porous coating, anatomical, and modular heads), and similar in intended use (uncemented) to the previously cleared DePuy Profile® Hip with Hydroxyapatite (K910156) and DePuy Profile® Hip (K850055).

Based on the information provided in this premarket notification, DePuy considers the DePuy Profile® Hip with Porocoat® prosthesis to be substantially equivalent to uncemented hip prostheses that are currently legally marketed.

	Profile®Porocoat®(this submission)	StabilityK934457	Profile®Porocoat®K872776	Profile®HydroxyapatiteK910156	Profile®K850055
Intended Use	Uncemented	Uncemented	Cemented	Press-Fit	Press-Fit
Stem Material	Ti-6Al-4VASTM-620	Ti-6Al-4VASTM-620	Ti-6Al-4VASTM-620	Ti-6Al-4VASTM-620	Ti-6Al-4VASTM-620
ProximalSurface Coating	Porocoat®Porous-coating	Porocoat®Porous-coating	Porocoat®Porous-coating	Hydroxyapatite	None
Design	Anatomical	Anatomical	Anatomical	Anatomical	Anatomical
Modular Heads	Yes	Yes	Yes	Yes	Yes
Modular Taper	12/14mm	12/14mm	12/14mm	12/14mm	12/14mm

The following table summarizes the similarities:

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

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

Re: K984459 DePuy Profile® Femoral Hip with Porocoat® Trade Name: Requlatory Class: II Product Code: LPH December 14, 1998 Dated: December 15, 1998 Received:

Dear Ms. Foust:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ત substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Sally Foust

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 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.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known)_K984459

Device Name: DePuy Profile Femoral Hip with Porocoat: Additional Indication

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ X (Per 21 CFR 801.109) Over-The-Counter Use_

beall

(Divisior Division of General Restorative I 510(k) Number

000002

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.