APR OVERSIZED HIP STEM

K961921 · Intermedics Orthopedics · LZO · Aug 5, 1996 · Orthopedic

Device Facts

• Record ID: K961921
• Device Name: APR OVERSIZED HIP 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

The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement.

Device Story

Anatomic femoral component for hip replacement; addresses metaphyseal/diaphyseal mismatch in Type A endosteal canals; allows proximal upsizing for improved fit and fill without sacrificing distal cortical bone. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Device provides structural replacement of proximal femur; aids in restoring joint function and stability in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only; strength analyzed via theoretical calculations and fatigue loading conditions.

Technological Characteristics

Material: Wrought Ti-6Al-4V alloy (ASTM F 136). Design: Anatomic femoral component, porous and nonporous versions for cemented or press-fit applications. Form factor: Proximally upsized for Type A endosteal canals.

Indications for Use

Indicated for patients with rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, arthritis secondary to diseases/anomalies, avascular necrosis of the femoral head, non-union of femoral neck fractures, femoral fractures, and fracture dislocation of the hip.

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

• OMNIFIT® Specialty™ Femoral Stem (Osteonics Corp.)
• PFC™ Total Hip System (Johnson & Johnson, Inc.)
• Ranawat/Burstein™ Total Hip System (Biomet, Inc.)
• Stability™ Total Hip System (DePuy, Inc.)

Submission Summary (Full Text)

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# 510(k) SUMMARY

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 510(k) Summary for the Intermedics Orthopedics, Inc. APR® Oversized Hip Stem.

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

Date: May 15, 1996
AUG - 5 1996

Contact Person: Jacquelyn Hughes
Manager, Regulatory Affairs

Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 21 CFR 888.3358
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21CFR 888.3353

Common/Usual Name: Femoral Component

Trade/Proprietary: APR® Oversized Hip Stem

# Product Description/Substantial Equivalence:

The APR Oversized Hip Stem is an anatomic femoral component that is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is manufactured from wrought Ti-6Al-4V alloy (ASTM F 136) and is available in both porous and nonporous versions for use in cemented or press-fit applications. The APR Oversized Hip Stem will be offered with the intent of augmenting IOI's anatomic product line by addressing the metaphyseal/diaphyseal mismatch found in a significant portion of the patient population. While the currently marketed APR Hip Stem is a proportional design, the APR Oversized Hip Stem is designed for the Type A endosteal canal in which the diaphysis is disproportionately smaller than the metaphysis. By adding this "proximally upsized," or "oversized," version to the currently marketed product line, the surgeon can obtain good fit and fill of the medullary canal without sacrificing distal cortical bone in those patients which exhibit proximal/distal mismatch. Specific diagnostic indications for use of the APR Oversized Hip Stem include:

- patient conditions of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, and arthritis secondary to a variety of diseases and anomalies;
- avascular necrosis of the femoral head and/or non-union of femoral neck fractures;
- femoral fractures; and
- fracture dislocation of the hip.

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510(k) Summary
APR Oversized Hip Stem
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The strength of the APR Oversized Hip Stem was analyzed using theoretical calculations and fatigue loading conditions and shown to be comparable to other legally marketed devices.

The APR Oversized Hip Stem is substantially equivalent to the OMNIFIT® Specialty™ Femoral Stem (Osteonics Corp.), the PFC™ Total Hip System (Johnson & Johnson, Inc.), the Ranawat/Burstein™ Total Hip System (Biomet, Inc.), and the Stability™ Total Hip System (DePuy, Inc.).

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