WAGNER REVISION STEM

K960588 · Intermedics Orthopedics · LZO · Aug 5, 1996 · Orthopedic

Device Facts

• Record ID: K960588
• Device Name: WAGNER REVISION STEM
• Applicant: Intermedics Orthopedics
• Product Code: LZO · Orthopedic
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.

Device Story

Wägner Revision Stem; femoral component for hip arthroplasty. Features circular cross-section with eight longitudinal conical anchorage ribs (flutes) for distal cementless fixation. Used in clinical settings by orthopedic surgeons for revision cases involving proximal femoral bone loss. Device provides structural support for hip joint reconstruction. Subject of 510(k) is the addition of 345mm and 385mm stem lengths to existing product line. Sizes designed in proportion to existing 190-305mm stems. Strength verified via static and dynamic bench testing.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed to verify structural integrity and strength of the additional stem sizes.

Technological Characteristics

Femoral component with circular cross-section and eight longitudinal conical anchorage ribs. Cementless design for distal fixation. Available in lengths 190mm to 385mm. Material: Metal (implied by classification).

Indications for Use

Indicated for patients requiring hip joint replacement with deficiencies in the proximal femur due to extensive bone resorption or damage in the prosthetic bed, requiring cementless distal fixation.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Müller Type Proximal Femur (Howmedica)
• Proximal Third Femoral Prosthesis (DePuy)

Submission Summary (Full Text)

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AUG - 5 1996

K960588

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Wägner Revision Stem.

Submitter: Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
[phone]

Date: February 9, 1996

Contact Person: Jacquelyn Hughes
Manager, Regulatory Affairs

Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21CFR 888.3353

Common/Usual Name: Femoral component

Trade/Proprietary: Wägner Revision Stem

# PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE:

The Wägner Revision Stem incorporates a circular cross-section with eight equally spaced conical anchorage ribs (or flutes) which run the entire length of the stem. This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.

Currently, the Wägner Revision Stem is offered in four stem lengths (190, 225, 265 and 305mm) with distal diameters ranging from 14-20mm, 14-22mm, and 14-25mm (in 1mm increments) for the 190, 225, and 265/305mm lengths respectively. The number of size offerings is being increased to include a stem length of 345mm with distal diameters of 14-25mm (1mm increments) and a stem length of 385mm with distal diameters of 14-25mm (1mm increments).

The additional sizes are identical in configuration to the original Wägner Stems, but have been designed in proportion to the sizes already available. Static and dynamic testing were performed, verifying that the additional sizes exhibit sufficient strength for clinical use.

The modified Wägner Revision Stem is substantially equivalent to the Müller Type Proximal Femur marketed by Howmedica and the Proximal Third Femoral Prosthesis marketed by DePuy.

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