SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS

K960984 · Biomet, Inc. · JDI · Sep 17, 1996 · Orthopedic

Device Facts

• Record ID: K960984
• Device Name: SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SHP Hip System is a single use implant intended for use with bone cement.

Device Story

SHP Hip System; cemented hip prosthesis. Components: anatomic cobalt-chromium alloy femoral stem, modular head, all-polyethylene acetabular component. Design: Numerical Shape Optimization (NSO) based on 300 cadaver femurs; proximal surface roughened for cement adherence; PMMA spacers for placement; acetabular pegs for uniform cement mantle. Used in orthopedic surgery for total hip replacement. Reduces normal/shear stresses in cement mantle/interfaces per FEM analysis. Benefits: restores joint function, treats degenerative disease/fractures.

Clinical Evidence

No clinical data. Evidence based on bench testing, including Finite Element Method (FEM) analysis comparing stress distribution in cement mantle and interfaces against other femoral components.

Technological Characteristics

Materials: Cobalt-chromium alloy (femoral stem), polyethylene (acetabular component), PMMA (spacers). Design: Anatomically proportioned, 7 sizes (left/right), acetabular pegs. Principle: Cemented semi-constrained hip prosthesis. Software: None.

Indications for Use

Indicated for patients with non-inflammatory joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed joint reconstruction, or proximal femur fractures (nonunion, femoral neck, trochanteric) unmanageable by other techniques.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Reference Devices

• Rx90 Total Hip System (Biomet, Inc.)
• Centralign Precoat Hip Prosthesis (Zimmer, Inc.)
• Ranawat/Burstein Cemented Primary Series (Biomet, Inc.)
• Buchalter/Fauser Femoral Component (Biomet, Inc.)
• Premise Total Hip System (Howmedica)

Submission Summary (Full Text)

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Attachment II

Corporate Headquarters

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

Stamp: Address:
Airport Industrial Park
Warsaw, IN 46580

[phone] Office
[phone] FAX

K960984

# Summary of Safety and Effectiveness

Sponsor: Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0578

Device: SHP Hip System

Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)

Device Description: The Scientific Hip Prosthesis or SHP Hip System is composed of an anatomic cobalt-chromium alloy femoral stem with a modular head component and an all polyethylene acetabular component. The femoral component is anatomically proportioned, with sizing developed based on a computer analysis of 300 cadaver femurs to achieve a model of actual anatomic variation. The design was determined by Numerical Shape Optimization (NSO) and has been shown to reduce normal and shear stresses in the cement mantle and at the implant/cement and cement/bone interface as compared to other femoral components in an FEM analysis. The proximal surface is roughened to facilitate greater cement adherence. PMMA spacers assist in placement of the stem. The stem is available in seven sizes with left and right configurations. The acetabular component features pegs to ensure a more uniform cement mantle and is available in seven outer diameters.

Indications: Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.

The device is a single use implant intended for use with bone cement.

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 | Nerve Damage |
| --- | --- | --- |
| Deformity of the joint | Soft tissue imbalance | Bone fracture |
| Cardiovascular disorders | Delayed wound healing | Infection |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Excessive wear | Hematoma |
| Fracture of the component | | |

Substantial Equivalence: In function and overall design, the SHP Hip System is equivalent to many cemented hip components on the market. Commercially available devices for cemented use include:

- Rx90 Total Hip System (Biomet, Inc., Warsaw, IN)
- Centralign Precoat Hip Prosthesis (Zimmer, Inc., Warsaw, IN)
- Ranawat/Burstein Cemented Primary Series (Biomet, Inc., Warsaw, IN)
- Buchalter/Fauser Femoral Component (Biomet, Inc., Warsaw, IN)
- Premise Total Hip System (Howmedica, Rutherford, NJ)