ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS

K081860 · Zimmer, Inc. · LZO · Sep 26, 2008 · Orthopedic

Device Facts

• Record ID: K081860
• Device Name: ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General Indications for the Segmental System: This device is indicated for: Moderate to severe knee instability; Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle; Valgus, varus or flexion deformities; The salvage of previously failed surgical attempts. Indications specific to the Variable Stiffness Stem extensions: Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.

Device Story

Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments are orthopedic implants for femoral reconstruction. Stem extensions (straight or bowed) are used in proximal/mid-shaft femur; intercalary segments replace mid-shaft bone. Stem extensions require a cemented collar (smooth or Trabecular Metal) at the bone interface, while the remainder of the stem is used uncemented. Used by orthopedic surgeons in clinical settings to restore structural integrity in patients with significant bone loss or instability. Benefits include stabilization of the femur and salvage of failed prior surgeries. Device components are manufactured from Zimaloy (Co-Cr-Mo alloy) and Tivanium (Ti-6Al-4V alloy).

Clinical Evidence

No clinical data was required or provided for this device; substantial equivalence was established through non-clinical bench testing.

Technological Characteristics

Materials: Zimaloy (Cobalt-Chromium-Molybdenum alloy) for stem extensions; Tivanium (Ti-6Al-4V alloy) for intercalary segments. Fixation: Hybrid (cemented collar, uncemented stem). Form factor: Modular segmental system components including straight/bowed stem extensions and intercalary segments. Sterilization: Standard industry processes consistent with predicate devices.

Indications for Use

Indicated for patients with moderate to severe knee instability, significant bone loss or ligament deficiencies (due to neoplasms, trauma, arthritis, collagen disorders, or avascular necrosis), valgus/varus/flexion deformities, or those requiring salvage of failed surgical attempts.

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

• Zimmer Segmental System (K070978)
• MOST System (K960626, K973087)
• Orthogenesis LPS System Intercalary (K003182)

Submission Summary (Full Text)

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K081860

SEP 2 6 2008

# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel J. Williman<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | September 24, 2008 |
| Trade Name: | Zimmer® Segmental System Variable Stiffness<br>Stem Extensions and Intercalary Segments |
| Common Name: | Total Hip Prosthesis |
| Classification Name<br>and Reference: | Hip joint, metal/ceramic/polymer, semi-constrained,<br>cemented or nonporous uncemented prosthesis.<br>21 CFR § 888.3353 |
| Predicate Devices: | Zimmer Segmental System, manufactured by<br>Zimmer, Inc. (K070978, cleared July 03, 2007);<br><br>MOST System, manufactured by Intermedics<br>Orthopedics, Inc. (K960626, cleared April 18, 1996<br>and K973087, cleared November 14, 1997);<br><br>Orthogenesis LPS System Intercalary,<br>manufactured by DePuy, Inc. (K003182, cleared<br>June 27, 2001) |
| Device Description: | The Variable Stiffness Stem extensions are intended<br>to be used in the proximal and mid-shaft portion of<br>the femur. They are available in either straight or<br>bowed geometry and are made from Zimaloy™<br>Cobalt-Chromium-Molybdenum Alloy.<br><br>The Intercalary Segments are intended for the<br>replacement of the mid-shaft portion of the femur or<br>for use as a segment connected to other Zimmer®<br>Segmental System components. They are made. |

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K081860

p.2/2

from Tivanium™ Ti-6Al-4V Alloy.

#### General Indications for the Segmental System:

- This device is indicated for: .
- Moderate to severe knee instability
- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts

# Indications specific to the Variable Stiffness Stem extensions:

- Variable Stiffness stem extensions require the t use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.
These devices are manufactured, packaged and sterilized using the same materials and processes as the predicate devices. They also have the same intended use and fixation methods as the predicate devices.

Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective.

Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.

#### Intended Use:

# Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. c/o Daniel J. Williman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K081860 Trade/Device Name: Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary Segments Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: June 30, 2008 Received: July 1, 2008

Dear Mr. Williman:

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 (QS) 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 - Daniel J. Williman

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 vou 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melham

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

Enclosure

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K08186U

## Indications for Use

510(k) Number (if known):

Device Name:

Segmental Variable Stiffness Stems and Intercalary Segments

Indications for Use:

#### General Indications for the Segmental System:

- · This device is indicated for:
- Moderate to severe knee instability t
- । Significant bonc loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, and/or avascular necrosis of the femoral condyle
- Valgus, varus or flexion deformities -
- The salvage of previously failed surgical attempts ---

### Indications specific to the Variable Stiffness Stem extensions:

- · Variable Stiffness stem extensions require the usc of cither a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone, but the remainder of the stem must be used uncemented.
Mark N. Mellers

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

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)

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