ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS

K041872 · Biomet Manufacturing Corp · MBH · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041872
• Device Name: ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
• Applicant: Biomet Manufacturing Corp
• Product Code: MBH · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-cemented total knee replacement

Device Story

Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component used with Ascent™ tibial base-plate components. Includes modular distal femoral pegs for alignment in distal augment holes. Manufactured from CoCrMo alloy for non-cemented application. Used by orthopedic surgeons in total knee replacement procedures to address joint pain, disability, and deformity. Device provides structural replacement for damaged knee joint surfaces.

Clinical Evidence

No clinical data provided.

Technological Characteristics

CoCrMo alloy construction; porous-coated for uncemented fixation; modular distal femoral peg design; metallic femoral component; intended for use with Ascent™ tibial base-plate components.

Indications for Use

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

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Ascent™ Porous Open Box PS Femoral Component (K002678)
• Biomet Non-Cement (K033489)

Submission Summary (Full Text)

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#### 510(k) Summary

Applicant/Sponsor: Biomet, Inc.

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

#### Proprietary Name:

- 1) Ascent™ Porous Open Box PS Component
- 2) Ascent™ Posterior Stabilized (PS) Distal Femoral Pegs

Common Name: Ascent™ Knee System

Classification Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented (21 CFR 888.3565)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Ascent™ Porous Open Box PS Femoral Component (K002678) and Biomet Non-Cement (K033489).

Device Description: The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.

Intended Use: Non-cemented total knee replacement

Indications for Use: The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include:

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

Summary of Technologies: The device to be covered by this 510(k) is identical to devices covered by previously cleared 510(k) submissions for cemented application.

Clinical and Non-Clinical Testing: None provided

All trademarks are property of Biomet, Inc

MAHING ADDRESS 170). Box 58 ' Warsaw. IN 46581 0587

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SHIPPING ADDRESS 56 E. Bell Drive 1 - 1 - 1 - 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 57.1.267.6639

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E-MAII. [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K041872

Ro41672
Trade/Device Name: Ascent™ Porous Open Box PS Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Er Cr Fr 866.5565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBH Dated: July 8, 2004 Received: June 9, 2004

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the enclosure) to tegars and ment date of the Medical Device Amendments, or to commerce proof to May 20, 1976, the eccordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, manel are act include requirements for annual registration, listing of general controls provisions of arctice, 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 If your device is classified (600 world) also be regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Souncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toase oc advised that I Dri b rosan to evice complies with other requirements of the Act that I DI Has Intatutes and regulations administered by other Federal agencies. You must or any I cacal statuated and statisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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### Page 2 – Patricia Sandborn Beres

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (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) This iction will and in yourse organ finding of substantial equivalence of your device to a legally premaired 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 If you desire specific at notially at [phone]. Also, please note the regulation entitled, Contact the Office of Councemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Corpumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark A. Millerson

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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## Indications for Use

# 510(k) Number (if known): _ KO41872

Device Name: Ascent™Porous Open Box PS Femoral Component

Indications For Use:

- 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r aimal and dioublou kire one or more compartments are involved.
- 2) Correction of varus, valgus or posttraumatic deformity
- 2) Correction of revision of revision of possful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

**510(k) Number** K041873

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