HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS

K973164 · Howmedica Corp. · JWH · Nov 20, 1997 · Orthopedic

Device Facts

• Record ID: K973164
• Device Name: HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
• Applicant: Howmedica Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 20, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Howmedica® Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon® tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. The Howmedica® Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent. The Howmedica® tibial wedges are intended to be used with the Howmedica® Universal tibial baseplate to augment bone loss on the surface of the tibia. Tibial bone loss may be observed in primary or revision total knee arthroplasty. The Howmedica® Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting with respect to the intramedullary canal to allow optimal coverage of the prepared bone surfaces. The Howmedica® Stem Extenders are intended to be used with Duracon®/ Kinemax® femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required. The Howmedica® Total Stabilizer Knee Components are intended to be implanted using bone cement.

Device Story

Total knee arthroplasty system components; includes femoral component, tibial insert, modular offset adaptor, stem extenders, and tibial wedges. Used in conjunction with Duracon/Kinemax components. Provides mechanical stability for knee joints with absent or inadequate cruciate ligaments or patella. Implanted by orthopedic surgeons in clinical/hospital settings using bone cement. Components augment bone loss and provide structural support to restore joint function and relieve pain. Output is a reconstructed knee joint interface. Benefits include improved joint stability and pain relief in complex primary or revision cases.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Modular knee arthroplasty components including femoral, tibial, and augmentation hardware. Requires cemented fixation. Minimum polyethylene thickness of 8.6mm under condyles for 11mm insert. Designed for use with bone cement.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty to relieve pain and instability caused by non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically indicated when cruciate ligaments are absent, inadequate, or cannot be preserved, or when anterior-posterior stability is impaired due to absence of posterior cruciate ligament and/or patella. Collateral ligaments may or may not be intact. Requires cemented fixation.

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).

Reference Devices

• Duracon tibial and patellar components
• Duracon/Kinemax femoral/tibial components
• Howmedica Universal tibial baseplate

Submission Summary (Full Text)

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K973164
510(k) Summary

NOV 20 1997

## Device: Howmedica® Total Stabilizer Knee Components

The Howmedica® Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon® tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis.

The Howmedica® Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent.

The Howmedica® tibial wedges are intended to be used with the Howmedica® Universal tibial baseplate to augment bone loss on the surface of the tibia. Tibial bone loss may be observed in primary or revision total knee arthroplasty.

The Howmedica® Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting with respect to the intramedullary canal to allow optimal coverage of the prepared bone surfaces.

The Howmedica® Stem Extenders are intended to be used with Duracon®/ Kinemax® femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required.

The Howmedica® Total Stabilizer Knee Components are intended to be implanted using bone cement.

These components are substantially equivalent to other legally marketed devices. Comparisons to these components were presented, as well as testing included in the FDA Total Knee Guidance Document.

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For information contact:

: 上一篇:

Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard 000 - Color Cord, NJ 07070
[phone]

·

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Ms. Margaret F. Crowe Group Regulatory Affairs Manager Howmedica, Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

K973164 Re: Howmedica Total Stabilizer Knee Components ¨¨¨¨ Requlatory Class: II Product Code: JWH Dated: August 22, 1997 Received: August 25, 1997

Dear Ms. Crowe:

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 This decision is based on Food, Drug, and Cosmetic Act (Act). 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:

- The thinnest tibial insert available is the nominal 1. "11mm" sized insert, which has a minimum polyethylene thickness under the condyles of 8.6mm.
- 2. This device may not be labeled or promoted for non-cemented use.
- All labeling for this device, including package label 3 . and labeling included within the package, must ---prominently state that the device is intended for cemented use only.

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Page 2 - Ms. Margaret F. Crowe

- Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 Requlations.

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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Page 3 - Ms. Margaret F. Crowe

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,

Cenia 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: K973164

Device Name: Howmedica Total Stabilizer Knee Components

The Howmedica Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis.

The Howmedica Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent.

The Howmedica tibial wedges are intended to be used with the Howmedica Universal tibial baseplate to augment bone loss on the surface of the tibial bone loss may be observed in primary or revision total knee arthroplasty.

The Howmedica Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting to allow optimal coverage of the prepared bone surfaces.

The Howmedica Stem Extenders are intended to be used with Duracon/ Kinemax femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required.

The Howmedica Total Stabilizer Knee Components are intended to be implanted using bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ X ________ OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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(Divisiort Sign-Off)
Division of General Restorative Devices
510(k) Number. k973164