CEMENT-ON FEMORAL STEM

K963709 · Biomet, Inc. · JWH · Dec 4, 1996 · Orthopedic

Device Facts

• Record ID: K963709
• Device Name: CEMENT-ON FEMORAL STEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of revision of unsuccessful osteotomy or arthrodesis. This device is for use with bone cement.

Device Story

Cement-On Femoral Stem provides enhanced fixation for knee arthroplasty; used when soft tissues are intact but significant bone loss or fracture exists. Device consists of Co-Cr 6mm distal augment with 120mm intramedullary stem; angled at 7° valgus. Fixed to primary femoral component (AGC or Maxim systems) using bone cement. Used by orthopedic surgeons in clinical/OR settings. Enhances prosthetic stability; allows preservation of posterior cruciate ligament. Benefits patient by addressing bone loss/fracture during knee reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Co-Cr (Cobalt-Chromium) alloy construction. 6mm distal augment with 120mm intramedullary stem. 7° valgus angle. Fixed via bone cement. Available in six sizes. Designed for use with AGC and Maxim knee systems.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis; failure of previous joint replacement; correction of varus, valgus, or post-traumatic deformity; or revision of unsuccessful osteotomy/arthrodesis. Intended for use when soft tissues are intact but significant bone loss or fracture warrants intramedullary stem 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

• AGC 2000 Total Knee Prothesis (Biomet, Inc.)
• Maxim Knee System (Biomet, Inc.)
• Kinemax Plus Total Knee System (Howmedica)
• Genesis Total Knee System (Richards)

Submission Summary (Full Text)

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BIOMET

DEC - 4 1996

Corporate Headquarters

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587

Shipping Address:
Airport Industrial Park
Warsaw, IN 46580
[phone] Office
[phone] FAX

# SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0587

K963709

Device: Cement-On Femoral Stem

Classification Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prothesis (CFR 888.3560)

Intended Use: When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of revision of unsuccessful osteotomy or arthrodesis.

This device is for use with bone cement.

Device Description: The Cement-On Femoral Stem enhances fixation of prothesis to bone while still being able to maintain the posterior cruciate ligament. The stem is indicated when the soft tissues of the knee are intact but significant bony loss or fracture warrants the use of an intramedullary stem.

The Cement-On Femoral Stem is a Co-Cr 6mm distal augment with an attached 120mm long intramedullary stem. The stem is angled at 7° valgus and is fixed to the surface of the primary femoral component with bone cement.

The device is to be used with the appropriate AGC and Maxim knee components and is available in six different sizes.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

| Reaction to the bone cement | Blood vessel damage | Bone Fracture |
| --- | --- | --- |
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Inplant loosening/migration | Fracture of the component | Excessive wear |
| Nerve damage | | |

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Substantial Equivalence: In function and overall design, the Cement-On Femoral Stem is equivalent to other knee components on the market. These stems include:
- AGC 2000 Total Knee Prothesis (Biomet, Inc., Warsaw, IN)
- Maxim Knee System (Biomet, Inc., Warsaw, IN)
- Kinemax Plus Total Knee System (Howmedica, Rutherford, New Jersey)
- Genesis Total Knee System (Richards, Memphis, TN)

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