DEPUY MODULAR M HEADS

K060031 · DePuy Orthopaedics, Inc. · LPH · Jan 31, 2006 · Orthopedic

Device Facts

• Record ID: K060031
• Device Name: DEPUY MODULAR M HEADS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DePuy Modular M Heads are indicated for use in total hip replacement procedures. 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: 1. A 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 including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.

Device Story

Modular femoral heads for total hip arthroplasty; manufactured from wrought Co-Cr-Mo alloy. Device features internal tapers (12/14 Articul/eze or 11/13 S-ROM) to mate with compatible femoral stems. Designed to articulate with Pinnacle Marathon ES3 liners within Pinnacle Acetabular System shells in cementless applications. Available in 40, 44, and 48 mm diameters with varying neck lengths. Used by orthopedic surgeons in clinical settings to replace damaged hip joint articulation; aims to increase patient mobility and reduce pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Wrought Co-Cr-Mo alloy femoral heads; 12/14 Articul/eze or 11/13 S-ROM internal taper interfaces; 40-48 mm diameters; cementless application; semi-constrained hip prosthesis.

Indications for Use

Indicated for patients undergoing total hip replacement requiring joint articulation replacement due to osteoarthritis, traumatic/rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists to support components.

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

• DePuy ULTIMA Unipolar Femoral Heads (K033273)
• DePuy Articul/eze Femoral Heads (K980513)
• DePuy 36 mm Femoral Heads (K980513, K851422)

Reference Devices

• Pinnacle Acetabular System (K033338)

Submission Summary (Full Text)

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JAN 3 ] 2006

K06003/ pacific

# 510(k) SUMMARY

| NAME OF FIRM: | DePuy Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581 |
|-----------------|------------------------------------------------------------------------------|
| 510(k) CONTACT: | Keli Hankee<br>Clinical Research Associate |
| TRADE NAME: | DePuy Modular M Heads |
| COMMON NAME: | Femoral Heads |

## CLASSIFICATIONS:

888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

## DEVICE PRODUCT CODES:

87 JDI and 87 LPH

## SUBSTANTIALLY EQUIVALENT DEVICES:

- DePuy ULTIMA Unipolar Femoral Heads: K033273 (submitted as Pinnacle™ . Acetabular System)
- DePuy Articul/eze Femoral Heads: K980513 .
- DePuy 36 mm Femoral Heads: K980513, K851422 (cleared through internal . documentation.)

## DEVICE DESCRIPTION AND INTENDED USE:

The subject DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:

- 40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -- 2, +1.5, +5, . +8.5. +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
- 40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 . and +12 mm neck lengths. The 48 mm heads with the 11/13 S-ROM taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper

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Ko/003/ page 272

femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).

The subject device is designed to articulate with the Pinnacle™ Marahon®" ES3 Liners (K033273) inside a Pinnacle™ Acetabular System shell (K033338) in cementless applications.

DePuy Modular M Heads are indicated for use in total hip replacement procedures. 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:

- A severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid 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, 4. internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.

The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on design, method of manufacture, intended use, available diameter and indication, the subject device is found to be substantially equivalent to the comparison device, K033273.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

JAN 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Keli K. Hankee Clinical Research Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K060031 Re:

Trade/Device Name: DePuy Modular M Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: Class II

Product Code: LPH, JDI Dated: January 4, 2006 Received: January 5, 2006

Dear Ms. Hankee:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or prior to ria) 20, 20, 2017 11:27 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmotio Free (. Iot (. Iot) the device, subject to the general controls provisions of the Act. The 1 ou may, after systems 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not rnean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Keli K. Hankee

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Z

Mark N. Melkerson Acting 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): K060031

## Device Name: DePuy Modular M Head

## Indications for Use:

DePuy Modular M Heads are indicated for use in total hip replacement procedures. 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:

- 1. A 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 including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.

The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.

Prescription Use X

AND/OR Over-The-Counter Use Ne

(Title 21 CFR Part 801 Subpart D)

(Title 21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

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

KO60031 510(k) Number_