MERIDIAN TITANIUM FEMORAL STEMS

K972228 · Howmedica, Inc. · LZO · Dec 5, 1997 · Orthopedic

Device Facts

• Record ID: K972228
• Device Name: MERIDIAN TITANIUM FEMORAL STEMS
• Applicant: Howmedica, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Dec 5, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

Device Story

Meridian® Titanium Femoral Stems are orthopedic implants for primary or revision total hip arthroplasty; designed for press-fit fixation into proximal femur; do not rely on biological ingrowth. Components include titanium femoral stems with titanium plasma spray coating; used with Howmedica V40™ femoral heads, unipolar/bipolar components, and acetabular components. Implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support for hip joint reconstruction; benefits patient through restoration of hip function.

Clinical Evidence

Bench testing only; fatigue endurance testing performed in accordance with ISO standards.

Technological Characteristics

Substrate alloys: Ti-6Al-4V (ASTM F 136) or TMZF (Ti-11.5 Mo-6Zr-2 Fe). Coating: CP titanium plasma spray (ASTM F 1580). Design: Press-fit femoral stem. Energy source: N/A (mechanical implant).

Indications for Use

Indicated for patients undergoing primary or revision total hip arthroplasty requiring a press-fit femoral stem component.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Meridian® Femoral Stem (K940307)
• Osteolock™ CL Femoral Stem, TMZF (K944592)
• Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141)
• Osteonics' Arc Deposition Hip Components

Submission Summary (Full Text)

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### 510(k) Summary

Proprietary Name: Meridian® Titanium Femoral Stems

Common Name: Press-Fit Titanium Femoral Stem

9722228

21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LZO

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Telephone: [phone] [phone] Fax: Date Summary Prepared: 6-12-97

The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

These femoral components will be made available in two substrate alloys: 1) Ti-6Al-4V, which meets the requirements of ASTM specification F 136 or 2) TMZF alloy (Ti-11.5 Mo-6Zr-2 Fe). The TMZF alloy is the subject of a draft ASTM specification. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

The substantial equivalence of the Meridian® Titanium Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® Femoral Stem (K940307), Osteolock™ CL Femoral Stem, TMZF (K944592), and Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141): and Osteonics' Arc Deposition Hip Components.

Fatigue endurance testing in accordance with ISO standards was presented.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

DEC - 5 1997

Re: K972228 Meridian® Titanium Femoral Stems Regulatory Class: II Product Code: LZO Dated: September 23, 1997 Received: September 23, 1997

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

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Page 2 - Mr. Frank Maas

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(C) the device cleared for marketing by this letter as requiring postmarket The rationale for this decision is contained in surveillance. the enclosed attachment.

Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.

Submit five (5) copies to:

Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850

Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been Data generated under an unapproved protocol may not approved. satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).

Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In

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## Page 3 - Mr. Frank Maas

accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(1)(C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.

If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [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 Manufacturers Assistance at its toll-free number [phone] at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to costello

ia M. Witten) Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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irc - 5 199

### 510(k) Summary

Proprietary Name: Meridian® Titanium Femoral Stems

Common Name: Press-Fit Titanium Femoral Stem

9722228

21 CFR 888.3353 Classification Name and Reference: Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis.

Proposed Regulatory Class: Class II

Device Product Code: LZO

For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford. NJ 07070 Telephone: [phone] [phone] Fax: Date Summary Prepared: 6-12-97

The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

These femoral components will be made available in two substrate alloys: 1) Ti-6Al-4V, which meets the requirements of ASTM specification F 136 or 2) TMZF alloy (Ti-11.5 Mo-6Zr-2 Fe). The TMZF alloy is the subject of a draft ASTM specification. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

The substantial equivalence of the Meridian® Titanium Femoral components is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Howmedica's Meridian® Femoral Stem (K940307), Osteolock™ CL Femoral Stem, TMZF (K944592), and Osteolock™ CL Femoral Stem, Ti-6Al-4V (K941141): and Osteonics' Arc Deposition Hip Components.

Fatigue endurance testing in accordance with ISO standards was presented.

{5}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

DEC - 5 1997

Re: K972228 Meridian® Titanium Femoral Stems Regulatory Class: II Product Code: LZO Dated: September 23, 1997 Received: September 23, 1997

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

{6}------------------------------------------------

Page 2 - Mr. Frank Maas

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(C) the device cleared for marketing by this letter as requiring postmarket The rationale for this decision is contained in surveillance. the enclosed attachment.

Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.

Submit five (5) copies to:

Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850

Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been Data generated under an unapproved protocol may not approved. satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).

Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In

{7}------------------------------------------------

## Page 3 - Mr. Frank Maas

accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(1)(C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.

If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [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 Manufacturers Assistance at its toll-free number [phone] at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to coelle

ia M. Witten) Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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### Indications for Use

# 510(k) Number (if known): К9722228

Device Name: Meridian® Titanium Femoral Stems

Indications for Use:

The Meridian® Titanium Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary or revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

Over-The-Counter Use_

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Division of General Restorative Devices

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Division of General Restorative Devices

510(k) Number. K972228