ZIMMER POROLOCK MIS STEM

K071723 · Zimmer GmbH · KWA · Mar 7, 2008 · Orthopedic

Device Facts

• Record ID: K071723
• Device Name: ZIMMER POROLOCK MIS STEM
• Applicant: Zimmer GmbH
• Product Code: KWA · Orthopedic
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; Those patients with failed previous surgery where pain, deformity, or dysfunction persists; Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

Device Story

Zimmer Porolock MIS Stem is a modular femoral stem for total or hemi-hip arthroplasty. Device features curved, uncemented design with proximal Titanium Vacuum Plasma Sprayed (Ti-VPS) coating and distal rough-blasted surface. Available in multiple sizes to accommodate varying patient morphologies; utilizes 12/14 taper. Implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support for hip joint reconstruction; intended to restore mobility and reduce pain in patients with degenerative joint disease or failed prior arthroplasty. Fixation is uncemented.

Clinical Evidence

Bench testing only. No clinical data provided. Non-clinical performance testing confirmed the device met requirements and is as safe and effective as the predicate devices.

Technological Characteristics

Modular femoral stem; uncemented; proximal Titanium Vacuum Plasma Sprayed (Ti-VPS) coating; distal rough-blasted surface; 12/14 femoral taper; multiple sizes available.

Indications for Use

Indicated for total or hemi-hip arthroplasty in patients with noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory degenerative joint disease (e.g., rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed hip arthroplasty. Applicable to younger patients if benefits outweigh age-related risks and activity/loading demands are managed. For uncemented use only.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Zimmer M/L Taper Hip Prosthesis (K032726)
• Durom® Acetabular Component and Metasul® LDH™ Large Diameter Heads (K053536)
• Alloclassic® Zweymueller® SL/SLL Femoral Stem (K030373)

Submission Summary (Full Text)

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## 1071723

## Summary of Safety and Effectiveness

| Submitter: | Zimmer GmbH<br>Sulzer Allee 8<br>Winterthur, Switzerland CH-8404 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, MS, RAC<br>Senior Associate, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 24, 2007 |
| Trade Name: | Zimmer® Porolock" MIS Stem |
| Common Name: | Total Hip Prosthesis |
| Classification Name and Reference: | 1. KWA - Hip joint metal/metal semi-constrained<br>with uncemented acetabular shell, 21 CFR § 888.<br>3330<br>2. JDL - Hip joint metal/metal semi-constrained<br>with cemented acetabular shell, 21 CFR § 888. 3320<br>3. LZO - Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented<br>prosthesis, 21 CFR § 888.3353<br>4. KWY - Hip joint femoral (hemi-hip)<br>metal/polymer cemented or uncemented prosthesis,<br>21 CFR § 888.3390<br>5. KWL - Hip joint femoral (hemi-hip) metallic<br>cemented or uncemented prosthesis, 21 CFR §<br>888.3360<br>6. LWJ - Hip joint femoral (hemi-hip) metallic<br>cemented or uncemented prosthesis, 21 CFR §<br>888.3350<br>7. JDI - Hip joint metal/polymer semi-constrained<br>cemented prosthesis, 21 CFR § 888.3310<br>8. KWZ - Hip joint metal/polymer constrained<br>cemented or uncemented prosthesis, 21 CFR §<br>888.33 |

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| Predicate Device: | Zimmer M/L Taper Hip Prosthesis, manufactured<br>by Zimmer, Inc., K032726, cleared October 22,<br>2003.<br><br>Durom® Acetabular Component and Metasul®<br>LDH™ Large Diameter Heads, manufactured by<br>Zimmer GmbH, K053536, cleared March 16, 2006.<br><br>Alloclassic® Zweymueller® SL/SLL Femoral Stem,<br>manufactured by Zimmer GmbH, K030373, cleared<br>March 6, 2003. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Zimmer Porolock MIS Stem is a modular<br>femoral stem intended for total or hemi-hip<br>arthroplasty. The curved, uncemented stem and is<br>coated proximally with Titanium Vacuum Plasma<br>Sprayed (Ti-VPS) and rough-blasted distally. The<br>12/14 femoral stem is available in multiple sizes in<br>order to address different patient morphologies. |
| Intended Use: | This femoral stem is for total or hemi-hip<br>arthroplasty and is indicated for the following<br>conditions:<br>Patient conditions of noninflammatory degenerative<br>joint disease (NIDJD), e.g., avascular necrosis,<br>osteoarthritis, and inflammatory degenerative joint<br>disease (IJD), e.g., rheumatoid arthritis;<br><br>Those patients with failed previous surgery where<br>pain, deformity, or dysfunction persists;<br><br>Revision of previously failed hip arthroplasty.<br><br>Total hip replacements may be considered for<br>younger patients if any unequivocal indication<br>outweighs the risks associated with the age of the<br>patient and modified demands regarding activity<br>and hip joint loading are assured. This includes<br>severely crippled patients with multiple joint<br>involvement, for whom an immediate need of hip<br>mobility leads to an expectation of significant<br>improvement in the quality of their lives. |

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Comparison to Predicate Device:

The Zimmer Porolock MIS Stem is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

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:

: :

Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

Zimmer GmbH % Ms. Dalene T. Binkley Senior Associate, Warsaw Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708

Re: K071723 Trade/Device Name: Zimmer® Porolock® MIS Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, KWZ, JDL, LZO, KWY, KWL, LWJ, JDI Dated: March 3, 2008 Received: March 4, 2008

Dear Ms. Binkley:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Dalene Binkley

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K071723 Indications for Use

510(k) Number (if known):

Device Name:

Zimmer® Porolock® MIS Stem

## Indications for Use:

This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions; Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (I.D), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.

Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled pattents with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

This stem is for uncemented use only.

Prescription Use X (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)

Nil rella fr mxn

Division of Gene I, Restorative. and Neurological Devices

510(k) Number K671723

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