PATRIOT PROTRUSIO CAGE

K020076 · Biomet Orthopedics, Inc. · JDI · Jan 30, 2002 · Orthopedic

Device Facts

• Record ID: K020076
• Device Name: PATRIOT PROTRUSIO CAGE
• Applicant: Biomet Orthopedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jan 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.

Device Story

Patriot Protrusio Cage is a titanium acetabular implant used in hip joint reconstruction. Device features two superior iliac flanges and one inferior ischial flange with holes for screw fixation to the ilium and ischium. Provides structural integrity to compromised joints; optional augments attach via locking screw to fill bony defects. Implanted with bone cement; used with commercially available polyethylene acetabular cups. Intended for use by orthopedic surgeons in clinical settings. Benefits include restoration of structural support in revision or primary hip surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical bench testing.

Technological Characteristics

Material: Titanium. Design: Acetabular cage with iliac and ischial flanges for screw fixation. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for reconstruction of the hip joint in skeletally mature individuals due to disease, deformity, or trauma, including primary and secondary revision surgery.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Patriot Protrusio Cage (K001376)

Submission Summary (Full Text)

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

JAN 3 0 2002

K020076
page 1 of 1

ARTERS CORPORATE

## SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:

Biomet. Inc. 56 East Bell Drive P.O. Box 587 Warsaw, In. 46581-0587

Contact Person:

Tracy Bickel [phone]

Proprietary Name:

Common Name:

Acetabular Component

Patroit Protrusio Cage

Classification Name:

Hip joint metal/polymer/metal semi-constrained uncemented prosthesis (888.3358)

Patriot Protrusio Cage - K001376 Substantially Equivalent Devices:

This series of six anatomic protrusio cages is manufactured from Titanium. Each cage Device Description: has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint.

The device is a single use implant intended for implantation with bone cement.

In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.

Intended use: The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.

The Patriot Protrusio Cage material, design, sizing, and indications are similar Summary of Technologies: to or identical to the predicate devices.

Non-Clinical Testing: Testing determined that Patriot Protrusio Cage components presented no new risks and were: therefore, substantially equivalent to the predicate device.

Clinical Testing: None provided as a basis for substantial equivalence.

All Trademarks are property of Biomet, Inc.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

1

OFFICE 219.267.6639

FAX [phone]

E-MAIL רחוג[e-mail]

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 3 0 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

K020076 Re:

Trade Name: Patriot Protrusio Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/ metal semiporous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: January 7, 2002 Received: January 9, 2002

#### Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of re(i) prother is substantially equivalent (for the relerenced above and we have decembliod the evices marketed in interstate commerce prior to indications for use stact in the energian of the Medical Device Amendments, or to devices that have May 26, 1970, the chaculten date of the Frederal Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug, March Way been recrassified in accordance will a premarket approval application (PMA). You may, (Act) that do not require approval of to the general controls provisions of the Act. The general therefore, market the device, subject to the generals for annual registration, listing of devices. controls provisions of the rice merace sont prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can may be subject to such additional controller "Little 21, Parts 800 to 898. In addition, FDA may oc found in the Souv acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc advised that I DTT 3 ibsunted or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I catales and regarations and regarations and limited to: registration and listing (21 Comply with an the Aot 8 requirements, only, good manufacturing practice requirements as set CI K Fat 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality 35sems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Tracy J. Bickel

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse ough finding of substantial equivalence of your device to a legally promaticated predicated for 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 and 11 you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0071. Additionally, for questions on the promotion and advertising of Compliance at [phone] Fridae of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor general 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,

Mark N. Milken

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

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

Page ***_*** of **_**

510(k) Number (if known): __ ko2 0276 Device Name: Patriot Protrusio Cages Indications for Use:

The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, The Frounds in plants are intended for general use in skeletally mature individuals.
deformity or trauma. The devices are intended for general use in a mass implant undergoing primary and/or secondary revision surgery. The device is a single lise implant. undergoting primary and/or socondary revision with any commercially available polyethylene acetabular cup.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
OR
(Per 21 CFR 801,109)
for
Mark A. Melhern
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020076

Over-The-Counter Use (Optional Format 1-2-96)

0007b