MEDALLION MODULAR HIP SYSTEM

K041850 · Biomet Manufacturing, Inc. · LPH · Dec 21, 2004 · Orthopedic

Device Facts

• Record ID: K041850
• Device Name: MEDALLION MODULAR HIP SYSTEM
• Applicant: Biomet Manufacturing, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision of previously failed total hip arthroplasty.

Device Story

Medallion Modular Hip System is a femoral stem implant system for total hip arthroplasty. System features proximal female dovetail groove for modular trunnion attachment. Modular trunnions include distal male semi-dovetail projection; keyway defined between components; locking key prevents relative sliding. Used by orthopedic surgeons in clinical/surgical settings to replace diseased or fractured hip joints. Provides structural support for hip joint; restores function; alleviates pain associated with degenerative joint disease or fractures. Device is a mechanical implant; no software or electronic components.

Clinical Evidence

No clinical testing was conducted for this design. Substantial equivalence is supported by non-clinical bench testing.

Technological Characteristics

Modular femoral stem system; metal/polymer construction; uncemented porous-coated design. Features proximal female dovetail groove, modular trunnions, and locking key mechanism. Mechanical fixation principle. No software, electronics, or connectivity.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) unmanageable by other techniques, and for revision of failed total hip arthroplasty.

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

• Modular Hip Stem (Apex Surgical, LLC; K000788)
• PRO-FEMUR Hip System (Wright Medical Technology, Inc; K012091, K003016)
• Reach Femoral Component (Biomet, Inc; K000760)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC 2 1 2004

K041850 (pg 1 of 2)

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Lonnie Witham

Proprietary Name: Medallion Modular Hip System

Common Name: Total hip femoral component

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3558)

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Modular Hip Stem (Apex Surgical, LLC; K000788) .
- PRO-FEMUR Hip System (Wright Medical Technology, Inc; K012091, . K003016)
- Reach Femoral Component (Biomet, Inc; K000760) .

## Device Description:

The Medallion Modular Hip System is a complete system of femoral stem implants. The implants have a proximal female dovetail groove attachment site that is utilized for attaching various modular trunnions. The modular trunnions have a distal male semi-dovetail projection that engages the female dovetail groove on one side in such a way that a keyway is defined between the two components. The implants also include a key that is to be wedged in the keyway to lock the three components together and prevent relative sliding.

#### Intended Use:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 5) Revision of previously failed total hip arthroplasty.

Summary of Technologies: The Medallion Modular Hip System has the same indications for use, intended use, and materials as the predicate devices. Testing demonstrates that the design has sufficient strength for the intended use,

{1}------------------------------------------------

K041850 (pg 2 of 2.)

# Non-Clinical Testing:

The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues.

Clinical Testing: No clinical testing was conducted for this design.

All trademarks are property of Biomet, Inc.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2004

Mr. Lonnie Witham Senior Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K041850

Trade Name: Medallion Modular Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: July 7, 2004

Received: July 8, 2004

Dear Mr. Witham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 mean 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 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.

{3}------------------------------------------------

Page 2 - Mr. Lonnie Witham

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 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,

Celia M. Witten, Ph.D., M.

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

{4}------------------------------------------------

# 14041850

# Indications for Use

510(k) Number (if known):

Device Name: Medallion Modular Hip System

Indications For Use:

- Non-inflammatory degenerative joint disease including osteoarthritis and i 1) avascular necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Oomeolion of fanotional femoral neck fracture, and trochanteric 4) Treathent of the proximal femur with head involvement, unmanageable using other techniques
- acing other to treviously failed total hip arthroplasty. 5)

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

3

rence of CDRH, Office of Device Evaluation (ODE) Division of Gener

and Neurological Devic

Page 1 of 1

510(k) Number L041650