AML HIP PROSTHESIS

K003800 · DePuy Orthopaedics, Inc. · LPH · Feb 9, 2001 · Orthopedic

Device Facts

• Record ID: K003800
• Device Name: AML HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Device Story

AML Hip Prosthesis is a total hip joint replacement system; intended for cementless use. Device consists of a femoral hip stem manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy. Stem features a sintered porous coating (Porocoat) applied to the entire surface, excluding the tapered stem tip, to facilitate biological tissue ingrowth for fixation. Used by orthopedic surgeons in clinical settings to replace damaged hip joint articulations. Provides patients with increased mobility and pain reduction by replacing the femoral head and neck. Substantially equivalent to previously cleared hip systems based on design, material, and intended use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Femoral hip stem; material: ASTM F-75 Cobalt-Chromium-Molybdenum alloy; surface treatment: sintered porous coating (Porocoat) for biological fixation; cementless design; semi-constrained; metal/polymer/metal articulation.

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis. Indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Regulatory Classification

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.

Predicate Devices

• Porocoat® Prodigy™ Hip Prosthesis (K931641)
• Vision AML® Hip System (K953694)

Submission Summary (Full Text)

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### FEB - 9 2001

KOO3800 10-2

### 510(k) Summary

Name of Sponsor:

510(k) Contact:

Trade Name:

Common Name:

Classification:

Device Product Code:

Substantially Equivalent Device:

Device Descriptions:

Intended use:

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

Marcia J. Arentz Senior Regulatory Associate Phone: [phone] FAX: [phone]

#### AML® Hip Prosthesis

Total Hip Joint Replacement Prosthesis with porous coating

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

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.

Porocoat® Prodigy™ Hip Prosthesis K931641 Vision AML® Hip Prosthesis K953694

The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered 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.

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.

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K003800
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# 510(k) Summary (continued)

Indications for use:

Total hip replacement is indicated in the following conditions:

- Severely painful and/or disabled joint from l. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or 3. neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.

Based on similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use, DePuy believes that the modified AML Hip Prosthesis is substantially equivalent to the FDA cleared Prodigy Hip Prosthesis system (K931641) and the Vision AML Hip System (K953694).

#### Substantial equivalence:

## 0000000

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The text is in all caps and appears to be in a sans-serif font.

FEB = 9 2001

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: K003800

Trade Name: AML® Hip Prosthesis Regulatory Class: II Product Code: LPH Dated: December 7, 2000 Received: December 8, 2000

Dear Ms. Arentz:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your betermined 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 stated in the encrosure) to device Amendments, or to devices that have been reclassified in chacultion unto 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 therefore, market the device, bac) be requirements for annual registration, listing of devices, control provisions of the 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 (1 remanot ripped any 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 mspotions, and 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.

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#### Page 2 - Ms. Marcia J. Arentz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific articles your dones contact the Office of Compliance at additionally 607.10 for in viro daglestions on the promotion and advertising of your device, [phone]. Traditional), 18. quise at [phone]. Also, please note the regulation
10.01. prease connact the Ornec or Compitance as (2011) of the 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act 12011 110 (6607 monifacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerery, yours,

Mark M Melkerson

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

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## 510(k) Number (if known)v/ 00 3800

# Device Name: AML Hip Prosthesis

## Indications for Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing I otal hip artifically is thended to provide were is evidence of sufficient sound bone to seat
the damaged hip joint articulation in patients where there is evidence of suffi the damaged hip John articulation in patichis where in the following conditions:

- 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.
- Acule fraumatic fracture of the remoral nead or internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. ર.

The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth I he AML "Hip Stelli is indication for cemented use and fixation in which the porous coating serves as mto the porous counting as woon of the prostheses to the bone cement.

Concurrence of CDRH, Office of Device Evaluation

Mark M. Mulkerson

(Division Sign-Off) Division of General, Pestorative and Neurological Devices

KOO3800 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

OR