NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL

K062768 · Zimmer, Inc. · JWH · Oct 13, 2006 · Orthopedic

Device Facts

• Record ID: K062768
• Device Name: NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for patients with severe knee pain and disability due to: • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Collagen disorders, and/or avascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion deformities. • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Specific uses with LPS-Flex femorals: • Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. • The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Story

The NexGen LPS-Flex Fixed Bearing Tivanium Femoral Component is a semiconstrained, condylar knee prosthesis. It serves as a replacement component in total knee arthroplasty. The device is implanted by a surgeon in a clinical setting to address severe knee pain and joint dysfunction. It functions by providing stability and enabling increased flexion range (up to 155 degrees) in patients who have undergone excision of cruciate ligaments. The device is manufactured from Tivanium (Ti-6Al-4V) alloy. It is designed to prevent anterior subluxation of the femur relative to the tibia in flexion. The component is used in conjunction with compatible articular surfaces to restore joint function and improve patient mobility.

Clinical Evidence

Bench testing only; no clinical data was required or provided for this device modification.

Technological Characteristics

Material: Tivanium (Ti-6Al-4V) alloy. Design: Semiconstrained, condylar system. Form factor: Femoral component for fixed-bearing total knee prosthesis. Processing: Includes surface hardening. Sterilization: Not specified. Connectivity: N/A (mechanical implant).

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid, osteoarthritis, traumatic, or polyarthritis; collagen disorders; avascular necrosis of femoral condyle; post-traumatic joint loss; patellofemoral erosion/dysfunction; prior patellectomy; moderate valgus, varus, or flexion deformities; or salvage of failed surgical attempts. Specific use for patients desiring increased flexion range; intended for use with cruciate ligaments excised and load-bearing ROM ≤ 155 degrees.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Femoral and Articular Surface Components (K991581)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

# OCT 1 3 2006

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Anthony Francalancia<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] | |
| Date: | September 14, 2006 | |
| Trade Name: | NexGen® Complete Knee Solution Legacy®<br>Posterior Stabilized (LPS)-Flex Fixed Bearing<br>Tivanium® Ti-6Al-4V Alloy Femoral Components | |
| Common Name: | LPS-Flex Fixed Bearing Tivanium Femoral<br>Components | |
| Classification Name: | Knee joint patellofemorotibial<br>polyethylene/metal/polyethylene semiconstrained<br>cemented total knee prosthesis | |
| Classification Reference: | 21 CFR § 888.3560 | |
| Predicate Device: | NexGen® Complete Knee Solution Legacy®<br>Posterior Stabilized (LPS)-Flex Fixed Bearing<br>Femoral and Articular Surface Components,<br>manufactured by Zimmer, Inc., K991581, cleared<br>July 30, 1999 | |
| Device Description: | The LPS-Flex Fixed Bearing Knee is a<br>semiconstrained, condylar system for use without<br>the cruciate ligaments when additional stability is<br>required to prevent anterior subluxation of the<br>femur relative to the tibia in flexion. | |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to:<br>• Rheumatoid arthritis, osteoarthritis, traumatic<br>arthritis, polyarthritis.<br>• Collagen disorders, and/or avascular necrosis of<br>the femoral condyle. | |

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· Post-traumatic loss of joint configuration,

dysfunction or prior patellectomy.

particularly when there is patellofemoral erosion,

· Moderate valgus, varus, or flexion deformities. · The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in

Image /page/1/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. The "Z" is bold and black, and the word "zimmer" is also black and in a sans-serif font.

flexion cannot be obtained at the time of surgery. Specific uses with LPS-Flex femorals: · Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. · The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. Comparison to Predicate Device: Except for a change in material and surface hardening processing, the LPS-Flex Fixed Bearing Tivanium Femoral Components are identical to the predicate device's femoral components. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged using the same materials and processes. Performance Data (Non-clinical Non-Clinical Performance and Conclusions: and/or Clinical): The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for

this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

#### OCT 1 3 2006

Re: K062768

Trade/Device Name: NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6AI-4V Alloy Femoral

Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 14, 2006 Received: September 15, 2006

Dear Mr. Francalancia:

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 -- Mr. Anthony Francalancia

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w Jourse organ finding of substantial equivalence of your device to a legally premaince hourieation. The 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 active of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Other golfinational 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,

fa Vah

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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### Indications for Use

510(k) Number (if known):

K062768

#### Device Name:

NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS)-Flex Fixed Bearing Tivanium® Ti-6AI-4V Alloy Femoral Components

#### Indications for Use:

- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral connivale.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- Specific uses with LPS-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|------------------|---------------------------------------------|
| | AND/OR |
| | Over-The-Counter Use (21 CFR 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number: k06 2768