BRIDGE LONG STEM FEMORAL COMPONENT

K964249 · Wrightmedicaltechnologyinc · LZO · Jan 14, 1997 · Orthopedic

Device Facts

• Record ID: K964249
• Device Name: BRIDGE LONG STEM FEMORAL COMPONENT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: LZO · Orthopedic
• Decision Date: Jan 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BRIDGE™ Long Stem Femoral Component 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

BRIDGE Long Stem Femoral Component; hip prosthesis for total hip arthroplasty. Device features femoral stem with primary mid-shaft metal seal and secondary polyethylene seal. Available in 20 sizes (10 right, 10 left). Intended for cemented use only. Used by orthopedic surgeons in clinical/hospital settings to replace diseased or fractured hip joints. Provides structural support and joint function restoration; reduces pain; improves mobility. Clinical benefit derived from mechanical stabilization of femoral shaft.

Clinical Evidence

Bench testing only; fatigue strength testing performed to demonstrate mechanical integrity.

Technological Characteristics

Femoral stem prosthesis; metal construction with polyethylene mid-shaft seal. Designed for cemented fixation. 20 size variations. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for non-inflammatory/inflammatory degenerative joint disease (osteoarthritis, RA, AVN, ankylosis, protrusio acetabuli, hip dysplasia), functional deformity correction, revision procedures, or treatment of nonunion/proximal femur fractures with head involvement.

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

• BRIDGE Hip System (K964249)

Submission Summary (Full Text)

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JAN 14 1997

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

510(k) Summary
K964249

Contact Person: Cliff Kline
Date Prepared: September 23, 1996

Trade/Proprietary Name: BRIDGETM Long Stem Femoral Component
Common Name: Prosthesis, hip, semi-constrained, metal/ceramic/polymer/, cemented or non-porous, cemented
Product Classification: Class II (888.3353)
Predicate Device: The BRIDGETM 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 BRIDGETM Long Stem Femoral Component consists of two parts, a femoral stem designed with a primary mid-shaft metal seal and a polyethylene seal that provides a secondary seal at the mid-shaft region of the femoral stem. There are 20 sizes (ten right and ten left) for the BRIDGETM Long Stem Femoral Component. This device is intended for cemented use only.

The BRIDGETM Long Stem Femoral Component 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
The BRIDGE® Long Stem Femoral Component demonstrates acceptable fatigue strength.