CEMENTED CALCAR REPLACEMENT FEMORAL STEM

K964795 · Johnson & Johnson Professionals, Inc. · JDI · Feb 19, 1997 · Orthopedic

Device Facts

• Record ID: K964795
• Device Name: CEMENTED CALCAR REPLACEMENT FEMORAL STEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Feb 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.

Device Story

Cemented femoral component for total, partial, or revision hip arthroplasty. Features vertical/horizontal flanges for trochanteric/calcar support; macrotextured lateral surface; 2-lobed A/P hole for cable/wire anchoring. Standard lengths fluted distally with distal centralizer hole; long stems anatomically bowed. Used by orthopedic surgeons in clinical/OR settings. Provides structural support for deficient bone stock; enables fixation of greater trochanter or bony fragments via cabling. Benefits patients by restoring hip function and stability in cases of severe structural damage.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Cemented femoral stem; materials consistent with predicate hip prostheses. Features vertical/horizontal flanges, macrotextured lateral surface, 2-lobed A/P cable hole, and distal fluting. Available in standard and long (anatomically bowed) lengths; 10/12 and 12/14 trunnion tapers. Designed for use with PMMA bone cement. Sterilization method same as predicates.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock. For use only with PMMA bone cement.

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).

Predicate Devices

• Howmedica HNR with Porus Coating (K922503)
• Osteonics OmniFit Head/Neck Stem (K902712)
• ULTIMA Cemented Long Stem Femoral Component (K952859)

Reference Devices

• primary Ultima stems (K924379)

Submission Summary (Full Text)

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K96 4795
Summary of Safety and Effectiveness Data for the ULTIMA® Total Hip System Cemented Calcar Replacement Femoral Stem
Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, MA 02767-0350
FEB 19 1997

## Contact Person

Deana M. Boushell
Associate Regulatory Affairs Specialist
Phone: [phone]
Fax: [phone]

## Name of Device

| Proprietary Name: | Ultima® Cemented Calcar Replacement Stem |
| --- | --- |
| Common Name: | Cemented Calcar Replacement Femoral Stem |
| Classification Name: | Hip/joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class: | Class II by 21 CFR 888.3350 |
| Product Code: | 87 JDI |
| Owner/Operator No.: | 9001269 |

## Device Classification

This device has been placed in Class II for Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR § 888.3350.

## Statement of Substantial Equivalence

The Ultima Cemented Calcar Replacement Femoral Stem is substantially equivalent in function to both the Howmedica HNR with Porus Coating, cleared for marketing under premarket notification #K922503 (September 21, 1992) and the Osteonics OmniFit Head/Neck Stem, cleared for marketing under premarket notification #K902712 (August 9, 1990). Further, the Cemented Calcar Replacement Femoral Stem is substantially equivalent in material and design to the ULTIMA Cemented Long Stem Femoral Component, previously cleared for marketing under premarket notification #K952859 (January 31, 1996).

The subject device is composed of similar materials to the predicate devices mentioned above. Further, the intended use, design, and manufacture of the The Ultima Cemented Calcar Replacement Femoral Stem are substantially equivalent to those currently distributed. Additionally, the packaging and method of sterilization utilized for the The Ultima Cemented Calcar Replacement Femoral Stem are the same as those used for the previously mentioned predicate devices.

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# Indications for Use

The Ultima Total Hip System - Cemented Calcar Replacement Femoral Stem is indicated for use in total, partial, or revision hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint form rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic femoral fractures, and nonunion of femoral fractures. Use of the prothesis is also indicated for patients with congenital hip dysplasia, *protrusio acetabuli*, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

The Ultima Cemented Calcar Replacement Stem is indicated for use only with PMMA bone cement.

# Physical Description

The Ultima calcar replacement stem is a cemented femoral component for use in total or partial hip arthroplasty procedures. The stems are available in standard and long lengths. The standard length size range includes 3 base stem sizes, each available in 3 body lengths. The 3 base sizes are also each available in right and left long stem components; which are anatomically bowed. Also, the stems are available in 2 trunnion taper designs, i.e., 10/12 and 12/14.

The stem body design is derived from that of the primary Ultima stems #K924379. The proximal body of the Ultima cemented calcar stem, below the horizontal flange, is identical to that of the primary Ultima stems of equivalent size.

The Ultima calcar replacement stem features a vertical and horizontal flange, the former to provide support for the deficient or fractured greater trochanter and the latter to anatomically cap the resected calcar surface. The vertical flange has grooves located along it’s anterior and posterior edges to provide a constraint in cases where cables/wires are used. The lateral face of the vertical flange features a macrotextured surface finish to provide some resistance to movement of the greater trochanter against the lateral flange.

A 2-lobed A/P hole is provided proximal to the horizontal flange to enabling passing a cable/wire through the stem when it is necessary to anchor the greater trochanter and/or a proximal bony fragment to the stem. The medial aspect of the stem immediately proximal to the horizontal flange features a gentle radius to enable cabling/wiring around the stem if necessitated.

The distal aspect of the standard length stems are fluted to provide resistance to rotational movement of the stem. The standard length stems also feature a distal hole to accept an optional PMMA distal centralizer component. The long stems are anatomically bowed to pass the isthmus and thereby bypass actual or potential bony defects.