THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS

K031462 · Implex Corp. · MBH · Aug 6, 2003 · Orthopedic

Device Facts

• Record ID: K031462
• Device Name: THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
• Applicant: Implex Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty.

Device Story

Monoblock tibial and patellar components for NexGen Knee System; manufactured from Trabecular Metal (Hedrocel Porous Tantalum) and direct compression molded ultrahigh molecular weight polyethylene. Components articulate with Zimmer CR and LPS Femoral Components. Used in total knee arthroplasty procedures to replace damaged joint surfaces; implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support and articulation for knee joint; enables both cemented and cementless fixation options. Benefits patients by restoring joint function and alleviating pain associated with severe degeneration or trauma.

Clinical Evidence

Bench testing only. NexGen TMT Tibia, LPS Tibia, and Primary Porous Patella were tested per applicable standards, demonstrating performance as intended.

Technological Characteristics

Materials: Trabecular Metal (Hedrocel Porous Tantalum) and ultrahigh molecular weight polyethylene. Design: Monoblock construct. Fixation: Cemented or cementless. Regulatory Class: II (21 CFR 888.3565).

Indications for Use

Indicated for patients with severe knee joint degeneration, trauma, or other pathology requiring total knee arthroplasty, suitable for either cemented or cementless fixation.

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Trabecular Metal Tibial and Patellar Components for the NexGen Knee System

| Submitter Name: | Implex Corp. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person(s): | Marci Halevi |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | May 6, 2003 |
| Device Trade Name: | Trabecular Metal Tibial and Patellar Components for the<br>NexGen Knee System |
| Device Common Name: | Tibial and Patellar Components |
| Classification Name: | Knee Joint patellofemorotibial metal/polymer porous-<br>coated uncemented prosthesis |
| Substantial<br>Equivalence: | The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial<br>equivalence found in the Federal Food, Drug and<br>Cosmetic Act, as amended and as applied under 21 CFR<br>807, Subpart E under which a device can be marketed<br>without premarket approval or reclassification.<br>A<br>determination of substantial equivalency under this |

notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the

US Patent Laws or their application by the courts.

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510(K) Summary of Safety and Effectiveness - Continued...

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| Device Description: | Trabecular Metal Tibial and Patellar Components for the <i>NexGen</i> Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. |
| | These devices are of monoblock construct and are manufactured from Trabecular Metal (Hedrocel Porous Tantalum) and direct compression molded ultrahigh molecular weight polyethylene. |
| | The Trabecular Metal Tibial and Patellar Components for the <i>NexGen</i> Knee System articulate with the appropriate Zimmer CR and LPS Femoral Components. |
| Intended Use: | Trabecular Metal Tibial and Patellar Components for the <i>NexGen</i> Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | The predicate and subject devices are identical;<br>performance characteristics therefore remain as<br>documented in the predicate submissions. |
| Performance Data: | The <i>NexGen</i> TMT Tibia, LPS Tibia and Primary Porous Patella were all tested per applicable standards and the results demonstrated that the device will perform as intended. |
| Conclusion: | The Trabecular Metal Tibial and Patellar Components for the <i>NexGen</i> Knee System incorporates the identical materials, size options, technological design and geometry features as the legally marketed predicate devices described herein. The single difference is in the Indications for Use and associated changes to the Package Insert and Surgical Protocol, which will now incorporate the option for uncemented use. Review of 21.CFR 888.3565, Special Guidance Document for porous coated uncemented prosthesis, and the pre- clinical testing of the predicate (and subject) devices indicate no additional risk or change in safety or efficacy for the indicated and intended uses. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2003

Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K031462 Trade/Device Name: Trabecular Metal Tibial and Patellar Components for the NexGen Knee System Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: May 6, 2003 Received: May 8, 2003

Dear Ms. Halevi:

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

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## Page 2 - Ms. Marci Halevi

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. 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 Office 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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510(k) Number (if known):

Device Name:

Trabecular Metal Tibial and Patellar Components for the NexGen Knee System

<031462

Indications For Use:

Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee ioint indicates cemented or cementless total knee arthroplasty.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR...

Over-The-Counter Use

Muriam C. Provost

(Optional Format 1-2-96)

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

510(k) Number.