PERFECTA PLASMA SPRAY HIP STEM

K964218 · Wrightmedicaltechnologyinc · JDI · Jan 8, 1997 · Orthopedic

Device Facts

• Record ID: K964218
• Device Name: PERFECTA PLASMA SPRAY HIP STEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: JDI · Orthopedic
• Decision Date: Jan 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Story

Plasma spray coated femoral hip stem; titanium alloy (ASTM F-136) construction; standard/reduced flare configurations; collared/collarless options. Used in total hip arthroplasty; press-fit or cemented implantation. Device provides structural support for hip joint; restores function; relieves pain. Used by orthopedic surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Abrasion testing demonstrates plasma spray porous coating comparability to sintered bead coating. Validated finite element analysis confirms fatigue strength of worst-case subject device is comparable to predicate device.

Technological Characteristics

Material: Titanium alloy (ASTM F-136) with titanium plasma spray coating. Design: Femoral hip stem, standard/reduced flare, collared/collarless. Fixation: Press-fit or bone cement. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, failed prior treatments/devices, 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).

Predicate Devices

• PERFECTA® Plasma Spray Hip System (Wright Medical Technology, Inc.)
• PERFECTA® Revision Hip System (Wright Medical Technology, Inc.)

Submission Summary (Full Text)

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JAN 8 1997

K964218

WRIGHT
MEDICAL TECHNOLOGY, INC.
5677 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971

Contact Person: Cristie Manuel
Date: October 21, 1996

# 510(k) Summary

Trade/Proprietary Name: PERFECTA® Plasma Spray Hip System
Common Name: Plasma Spray Coated Femoral Hip Stem
Classification: Class II
Predicate Devices: PERFECTA® Plasma Spray Hip System and PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

# Description/Intended Use

The PERFECTA® Plasma Spray Hip System is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in standard and reduced flare configurations, collared and collarless. The stem is designed to be press-fit or can be used with bone cement.

The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity;
4) revision procedures where other treatments or devices have failed; and,
5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

# Testing

Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating.

Submitted validated finite element analysis indicates that the fatigue strength of the worst case subject device, the PERFECTA® 12mm reduced flare, collarless hip stem, is comparable to the fatigue strength of the predicate PERFECTA® 12mm calcar revision hip stem.

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