K Number

Device Name

TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS

Manufacturer

DEPUY, INC.

Date Cleared

1997-06-19

(211 days)

Product Code

LPH

Regulation Number

888.3358

Intended Use

The TCP-coated Porocoat AML® Fomoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating. This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate: - A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or theumatoid arthritis. - Avascular necrosis of the femoral head. - Acute traumatic fracture of the femoral head or neck. - Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. - Certain cases of ankylosis.

Device Description

The TCP-coated Porocoat® AML® Femoral Hip Prosthesis is a % porous coated, straightstemmed, collared prosthesis with a thin coating of tricalcium phosphate sprayed onto approximately ½ of the porous coating of the implant and is designed to be used as the femoral component in total hip replacement without cement.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

P820024, K941847

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical hip prosthesis and its intended use, with no mention of AI or ML technology in its design, function, or intended use.

Therapeutic

Yes
The device is a prosthesis designed to replace a severely painful or disabled joint, treating a medical condition.

Diagnostic

Explanation: The device is a femoral hip prosthesis, which is an implant used in total hip replacement surgery, not a diagnostic tool. Its use is determined by existing x-ray evidence, rather than performing diagnostic functions itself.

SaMD (Software as a Medical Device)

The device is a physical implant (femoral hip prosthesis) and not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
Device Description and Intended Use: The provided text clearly describes a femoral hip prosthesis, which is an implantable device used in surgery to replace a damaged hip joint. It is used within the body.
Input Imaging Modality: While the intended use mentions using "x-ray evidence," this is for assessing the patient's bone structure before the surgery and implanting the device. The device itself does not process or analyze these images to provide a diagnosis.

Therefore, based on the provided information, the TCP-coated Porocoat AML® Fomoral Hip Prosthesis is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:

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

Product codes

LPH, MEH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint, femoral head, femoral neck

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical results show that the TCPcoated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

P820024, K941847

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

JUN 19 1997

K96 41650

SAFE MEDICAL DEVICES ACT OF 1990 510K SAFETY AND EFFECTIVENESS SUMMARY

| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988 |
|-----------------------------------|-------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Vickie E. Arford, R.N.
Sr. Clinical Research Associate |
| TRADE NAME: | TCP-coated Porocoat® AML® Femoral Hip
Prosthesis |
| CLASSIFICATION NAME: | Prosthesis, Hip, Semi-constrained, Metal/Polymer,
Porous Uncemented, Calcium-Phosphate |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Inc. AML® 5/8 Porocoat® Femoral Implant
(P820024, K941847) |

INTENDED USE AND DEVICE DESCRIPTION:

The primary objective of total hip arthroplasty in general is to provide for increased mobility in the patient by reducing pain and replacing the damaged hip joint articulation.

This femoral hip prosthesis, with an appropriate Co-Cr-Mo alloy (Orthochrome®) metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

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

The TCP-coated Porocoat® AML® Femoral Hip Prosthesis is a % porous coated, straightstemmed. collared prosthesis with a thin coating of tricalcium phosphate sprayed onto approximately ½ of the porous coating of the implant and is designed to be used as the femoral component in total hip replacement without cement.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The TCP-coated Porocoat® AML® Femoral Hip Prosthesis and the DePuy Inc. AML® % Porocoat® Femoral Implant are both intended for cementless use as the femoral component in total hip replacement. The devices are identical except for the thin coating of TCP plasma sprayed onto approximately ½ of the proximal porous coating.Clinical results show that the TCPcoated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant.

SAFE MEDICAL DEVICES ACT OF 1990 510K SAFETY AND EFFECTIVENESS SUMMARY

INTENDED USE AND DEVICE DESCRIPTION:

The primary objective of total hip arthroplasty in general is to provide for increased mobility in the patient by reducing pain and replacing the damaged hip joint articulation.

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

BASIS OF SUBSTANTIAL EQUIVALENCE:

The TCP-coated Porocoat® AML® Femoral Hip Prosthesis and the DePuy Inc. AML® % Porocoat® Femoral Implant are both intended for cementless use as the femoral component in total hip replacement. The devices are identical except for the thin coating of TCP plasma spraved onto approximately ½ of the proximal porous coating.Clinical results show that the TCPcoated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant.

000004

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vickie E. Arford, R.N. Senior Clinical Research Associate DePuy Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana

JUN 1 9 1997

Re : K964650 TCP-coated Porocoat® AML® Femoral Hip Prosthesis Requlatory Class: II Product Codes: LPH and MEH Dated: March 20, 1997 Received: March 21, 1997

Dear Ms. Arford:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:

You may not label or in any way promote these devices for enhanced clinical or radiographic performance, enhanced biological fixation and/or lonq-term stable fixation. The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation, only) .

Page 2 - Vickie E. Arford, R.N.

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional -------limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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.

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

Page 3 - Vickie E. Arford, R.N.

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,

J. Collett

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

Enclosure

510(k) Number: K964650

Device Name: ICP-coated Porocoate AML Femoral Hip Prosthesis

Indications for Use:

A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic 】. arthritis, or theumatoid arthritis.
Avascular necrosis of the femoral head. 2.
Acute traumatic fracture of the femoral head or neck. 3.
Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, র্ব .
প্রশ্ন করে বাঁর পর করে বিশ্ববিদ্যালয় বিশ্ববিদ্যালয় প্রতিষ্ঠান করে বিশ্ববিদ্যালয় প্রতিষ্ঠান করে পারে পারে বিশ্ববিদ্যালয় প্রতিষ্ঠান করে পারে পারে পারে পারে পারে পারে পার hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
Certain cases of ankylosis. న.

Concurrence of CDRH, Office of Device Evaluation

cc Evaluation

(Division Sign-Off)
Division of General Restorative Devices

Prescription Usc (Per 21 CFR 801.109)

Over-the-Counter Use