MAXIM RPG PS FEMORAL COMPONENT

K012348 · Biomet, Inc. · JWH · Aug 15, 2001 · Orthopedic

Device Facts

• Record ID: K012348
• Device Name: MAXIM RPG PS FEMORAL COMPONENT
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maxim® RPG PS Femoral Component is indicated for: 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2) Correction of varus, valgus, or posttraumatic deformity. 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended for use with bone cement.

Device Story

Maxim® RPG PS Femoral Component is a cemented femoral knee prosthesis; constructed of Co-Cr-Mo alloy. Device features posterior stabilized (PS) design with femoral cam articulating against tibial polyethylene post to provide posterior femoral rollback. Modifications from predicate include changes to trochlear groove and PS box. Available in three sizes, right and left configurations. Used by orthopedic surgeons in clinical settings to reconstruct natural femur dimensions and kinematics during total knee arthroplasty. Output is physical structural support for knee joint; aids in pain relief and restoration of joint function.

Clinical Evidence

No clinical data. Substantial equivalence determined via mechanical analysis.

Technological Characteristics

Material: Co-Cr-Mo alloy. Design: Posterior stabilized femoral component with femoral cam. Fixation: Cemented. Configuration: Three sizes, right and left. Software: None.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments; patients requiring correction of varus, valgus, or posttraumatic deformity; and patients requiring revision of failed osteotomy, arthrodesis, or previous joint replacement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Maxim® PS Femoral Component

Submission Summary (Full Text)

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K012348

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Biomet. Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person:

Michelle L. McKinley Regulatory Specialist

Proprietary Name: Maxim® RPG PS Femoral Component

Common or Usual Name: femoral knee component

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560)

Device Classification: Class II

Device Product Code: 888.3560

Legally Marketed Device to which Substantial Equivalence is Claimed: Maxim® PS Femoral Component

#### Device Description:

The Maxim® RPG PS Femoral Components are composed of Co-Cr-Mo. The posterior stabilized femoral components provide posterior femoral rollback via a femoral cam that articulates with a polyethylene post on the tibial component. The minor modifications made were to the trochlear groove, and PS Box.

There are three sizes available in both right and left configurations for the Maxim® RPG PS Femoral Components. The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur.

#### Intended Use:

The Maxim® RPG PS Femoral Component is indicated for:

- 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where on or more compartments are involved.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Image /page/1/Picture/0 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is black and the background is white.

- 2) Correction of varus, valgus, or posttraumatic deformity.
- 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for use with bone cement.

Summary of Technologies: In terms of overall design, including geometry, materials, and fixation enhancements, as well as intended use, the Maxim® RPG PS Femoral Component is equivalent to the predicate device. Minor changes were made to the predicate femoral component.

Non-Clinical Testing: Mechanical analysis was completed to determine substantial equivalence.

Clinical Testing: Clinical testing was not used to determine substantial equivalence.

Maxim® is a registered trademark of Biomet,Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

ドヘメ 219.267.81300087

E-MAIL . [e-mail]

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Public Health Service

AUG 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle L. McKinley Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581

Re: K012348

Trade Name: Maxim® RPG PS Femoral Component Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: July 7, 2000 Received: August 4, 2000

Dear Ms. McKinley:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 510(x) flouintially equivalent (for the indications for use to May 28, 1076, the above and we nave determined the devices marketed in interstate commerce provinces has needsessified in stated in the eliebourcy to device Amendments, or to devices that have been reclassified in your cou enactifield date of the Medical Dovice Parlena. Food, Drug, and Cosmetic Act (Act). You mays accordance with the provisions of the reachers' rood, of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions or the neater request required in the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major regulations (Premarket Approval), it may of subject to oder as a subteral Regulations, Title 21, Parts 800 to 895. allecting your device can or round nation assumes compliance with the current Good A Substantally oquirvatent downent, as set forth in the Quality System Regulation (QS) for Manufacturing I ractio regulation (21 CFR Part 820) and that, through periodic (QS) Medical Devices. General regulation (FDA) will verify such assumptions. Fallure to inspections, the rood and Drug Nammouties (1 x 2 x 1 x 1 x addition, FDA may publish contply with the GMI Tegatation into readeral Register. Please note: this response to your premarks contonting your submission does not affect any obligation you might It spollse to your promative no in 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) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Driving of succion for your device and thus, permits your device to proceed to the market.

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Page 2 - Dr. Walter Abendschein

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoentle arriver diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Traditional [phone]. 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 mormation on Jour rope at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Amplellestonfor

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):

Device Name: Maxim® RPG PS Femoral Component

Indications for Use:

The Maxim® RPG PS Femoral Component is indicated for:

- 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- 2) Correction of varus, valgus, or posttraumatic deformity.
- 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for use with bone cement.

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Brmhheurofmann
Division Sign Off

Division of General, Restorative and Neurological Devic

510(k) Number K012348