INTERMOORE FRACTURE HIP STEM (MODIFY)

K963155 · Intermedics Orthopedics · LWJ · Oct 1, 1996 · Orthopedic

Device Facts

• Record ID: K963155
• Device Name: INTERMOORE FRACTURE HIP STEM (MODIFY)
• Applicant: Intermedics Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Oct 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty).

Device Story

InterMoore Fracture Hip Stem; femoral prosthesis for total hip replacement or hemi-arthroplasty. Device replaces proximal femur; straight stem design; available in multiple sizes/offsets (32-49mm) to replicate anatomy. Features: broad collar; 12/14 Morse-type male taper for modular femoral head/bipolar compatibility; I-beam grooves for rotational stability; grit-blasted surface for fixation; fenestrated or solid options. Fenestrated design includes proximal lateral fin. Used by orthopedic surgeons in clinical settings. Benefits: restores hip joint function; provides rotational stability; allows anatomical replication.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cast, forged, or wrought Cobalt-Chromium (CoCr) alloy per ASTM F75, F799, F1537. Design: Straight stem, 12/14 Morse-type taper, grit-blasted surface, I-beam grooves. Fenestrated or solid configurations. Mechanical fixation (press-fit or cemented).

Indications for Use

Indicated for patients requiring prosthetic replacement of the proximal femur for total hip replacement or hemi-arthroplasty.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Apollo Hip Stem (Intermedics Orthopedics, Inc.)
• Modular Austin Moore Hip Stem (Zimmer, Inc.)
• Bio-Moore II Stem (Biomet, Inc.)
• Hip Fracture Stem (Howmedica, Inc.)

Submission Summary (Full Text)

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OCT 1 1996

K96 3155

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration 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 InterMoore Fracture Hip Stem.

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

Date: September 20, 1996

Contact Person: Jacquelyn Hughes
Manager, Regulatory Affairs

Classification Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis, 21CFR 888.3360

Common/Usual Name: Hip Stem for Hemi-Arthroplasty or Total Hip Replacement

Trade/Proprietary Name: InterMoore Fracture Hip Stem

# PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE

The InterMoore Fracture Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in hip replacements (i.e., total hip replacement or hemi-arthroplasty). This device will be manufactured from either cast, forged, or wrought Cobalt-Chromium (CoCr) alloy conforming to ASTM Standards F75, F799, and F1537, respectively. This straight stem is offered in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a femoral replacement. In addition, the InterMoore Fracture Hip Stem:

- has a broad collar which wraps around the anterior, medial, and posterior sides.
- incorporates a stem-neck angle which replicates natural anatomy.
- is available in a fenestrated design for press-fit applications and a solid design for press-fit and cemented applications.
- has a 12/14 Morse-type male taper making it compatible with any Intermedics Orthopedics, Inc. 12/14 metal femoral head (e.g., modular femoral head, unipolar) or bipolar component which utilizes a 12/14 modular femoral head.
- provides lateral offsets ranging from 32 to 49mm.
- incorporates I-beam grooves along the anterior and posterior surfaces to increase rotational stability in vivo.
- has a roughened/grit-blasted surface below the collar, to enhance fixation in vivo.
- will incorporate a proximal, lateral fin to the fenestrated design. This fin will increase the rotational stability of the implant in vivo.

The InterMoore Fracture Hip Stem is substantially equivalent to the Apollo Hip Stem™ offered by Intermedics Orthopedics, Inc., the Modular Austin Moore Hip Stem offered by Zimmer, Inc., the Bio-Moore II Stem offered by Biomet, Inc. and the Hip Fracture Stem offered by Howmedica, Inc.

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