IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM

K981560 · Implex Corp. · JWH · Jun 8, 1998 · Orthopedic

Device Facts

• Record ID: K981560
• Device Name: IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
• Applicant: Implex Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for: - Total Knee Replacement in severely disabled joints as a result of degenerative a) arthritis; - Secondary revision of a previously unsuccessful tibial component; b) - Other knee problems where clinical experience has shown that alternative c) modes of treatment are less likely to achieve satisfactory results; - d) Trauma, or other fractures in which adequate bony fixation cannot be obtained; - Non-union of the proximal tibia; and e) - f) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

Device Story

The Implex Continuum Knee System Porous Tibial Component is a prosthetic implant designed for cemented total knee arthroplasty. Machined from forged titanium, the component provides fatigue strength and load transfer for the proximal tibia. It is intended for use by orthopedic surgeons in clinical settings to replace severely degenerated or traumatized knee joints. The device is fixed to the bone using acrylic bone cement. By providing a stable, biocompatible tibial surface, the implant aims to restore joint function and alleviate pain in patients with severe knee pathology or failed prior arthroplasty. The device is strictly contraindicated for non-cemented use.

Clinical Evidence

Bench testing only. The device underwent mechanical performance testing in accordance with CDRH-recognized standards and 21 CFR 820.30 design verification requirements to demonstrate substantial equivalence.

Technological Characteristics

Material: Forged titanium. Design: Porous tibial component for cemented total knee arthroplasty. Fixation: Cemented only. Manufacturing: Machined. Compliance: 21 CFR 820.30 design verification.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to severe degeneration, trauma, or pathology of the knee joint. Specific indications include degenerative arthritis, secondary revision of unsuccessful tibial components, knee conditions where alternative treatments are unlikely to succeed, trauma/fractures with inadequate bony fixation, non-union of the proximal tibia, and salvage of failed primary or secondary total/uni-knee arthroplasty. Intended for cemented use only.

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

• Implex Corp Continuum Knee System (K882322)
• Osteonics Series 7000 (K940813)
• Smith & Nephew Genesis II (K951987)
• Howmedica Duracon (K926228)

Submission Summary (Full Text)

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Submitted by: Implex Corp.

K981560

## JUN - 8 1998

## 510(k) SUMMARY - IMPLEX CK Porous Tibial Component, Cemented

| Submitter Name: | Implex Corp. |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Establishment<br>Registration Number: | 2247737 |
| Contact Person(s): | John Schalago, RAC, Regulatory Affairs Department<br>Robert, Poggie, Ph.D, Applied Science |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | April, 1998 |
| Device Trade Name: | Implex Continuum Knee System: Porous Tibial Component,<br>Cemented |
| Device Common Name: | Tibial Component |
| Classification Name: | Prosthesis, Knee, Tibial Component, Cemented |
| Substantial 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. A<br>determination of substantial equivalency under this<br>notification is not intended to have any bearing<br>whatsoever on the resolution of patent infringement suits<br>or any other patent matters. No statements related to, or<br>in support of substantial equivalence herein shall be<br>construed as an admission against interest under the US<br>Patent Laws or their application by the courts. |

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without significantly sacrificing coverage of proximal tibia. Components are machined from forged titanium, which provides excellent fatigue strength, load transfer and biocompatibility. For use where severe degeneration, trauma, or other Intended Use: pathology of the knee joint indicates cemented total knee arthroplasty. This device is intended for cemented use only. The CK Porous Tibial Tray has demonstrated acceptable Performance Data: performance in mechanical tests that were conducted in accordance with CDRH recognized standards and Design Verification requirements of 21 CFR § 820.30. Implex Corp believes that the CK Porous Tibial Tray is Subtantial Equivalence substantially equivalent to the predicate devices in the table below. This determination of substantial equivalence is supported by a comparison of the intended use, technological characteristics, dimensions, geometry, materials and configuration.

The manufacturer name, device name, 510(k) number and 510(k) clearance date of the predicate devices are provided below:

| Manufacturer | Device Name | 510(k) Number | Clearance Date |
|----------------|-----------------------|---------------|----------------|
| Implex Corp | Continuum Knee System | K882322 | 2/8/89 |
| Osteonics | Series 7000 | K940813 | 1/30/95 |
| Smith & Nephew | Genesis II | K951987 | 8/22/95 |
| Howmedica | Duracon | K926228 | 2/22/94 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 1998

John A. Schalago, RAC Requlatory Affairs Manager Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Re : K981560 Implex Continuum Knee System: Porous Tibial Component Requlatory Class: II Product Code: JWH Dated: April 30, 1998 Received: May 1, 1998

Dear Mr. Schalago:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- 1. This device may not be labeled or promoted for noncemented use... ... ..
- 2. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for .......... cemented use only.
- 3. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

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Page 2 - John A. Schalago, RAC

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to 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.

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

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Paqe 3 - John A. Schalago, RAC

obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | |
|---------------------------|--|
|---------------------------|--|

<981560

Device Name:

Implex Continuum Knee Porous Tibial Component

Indications For Use:

The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for:

- Total Knee Replacement in severely disabled joints as a result of degenerative a) arthritis;
- Secondary revision of a previously unsuccessful tibial component; b)
- Other knee problems where clinical experience has shown that alternative c) modes of treatment are less likely to achieve satisfactory results;
- d) Trauma, or other fractures in which adequate bony fixation cannot be obtained;
- Non-union of the proximal tibia; and e)
- f) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | 2981560 |

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR... | | Over-The-Counter Use | |
|------------------------------------------|---|-------|--|----------------------|--|
|------------------------------------------|---|-------|--|----------------------|--|

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