STRYKER CEMENT REMOVAL SYSTEM

K961101 · Stryker Corp. · LZV · Jul 15, 1996 · Orthopedic

Device Facts

• Record ID: K961101
• Device Name: STRYKER CEMENT REMOVAL SYSTEM
• Applicant: Stryker Corp.
• Product Code: LZV · Orthopedic
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.

Device Story

System removes PMMA distal cement plugs during revision hip arthroplasty; consists of rechargeable handpiece, disposable stainless steel tip, reusable slide hammer, battery charger. Handpiece heats tip to soften cement; tip inserted into plug; irrigation applied to resolidify cement around tip; slide hammer used for mechanical extraction via impact loading. Used by surgeons in OR. Benefits include efficient cement plug removal; risks include thermal injury, fume toxicity, tip breakage, bone fracture. Safety validated via comparative data against existing heat-generating cement removal systems.

Clinical Evidence

Bench testing and comparative data collected at University of Michigan and Michigan State University. Evaluated thermal injury risks, fume toxicity, and mechanical performance. Results demonstrated no new safety issues compared to existing heat-generating cement removal systems; fume production levels comparable to hand-mixing bone cement.

Technological Characteristics

Components: rechargeable handpiece (Ni-Cd batteries), disposable stainless steel tip, reusable slide hammer, battery charger. Principle: thermal softening of PMMA cement followed by mechanical extraction via impact loading. Irrigation system for cement resolidification.

Indications for Use

Indicated for revision hip arthroplasty patients requiring removal of old PMMA distal cement plug between primary implant distal tip and proximal bony restriction. Contraindicated for patients with unrestored fractures, severe osteoporosis, or cement plugs distal to medullary canal bony restrictions.

Regulatory Classification

Identification

A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Reference Devices

• Biomet, Inc. cement removal systems

Submission Summary (Full Text)

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stryker

INSTRUMENTS

4100 East Milham Avenue

Kalamazoo, MI 49001-6197

[phone] [phone]

K961101

JUL 15 1996

## Device Name:

Classification Name: Cement Removal/Extraction System: 87LZV, Class II

Common/Usual Name: Cement Removal System

Proprietary Name: Stryker Cement Removal System

## Device Sponsor:

Stryker Corporation
Instruments Division
4100 E. Milham
Kalamazoo, MI 49001
Registration No: 1811755

## Regulatory Class:

Class II

## Summary of Safety and Effectiveness:

The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.

The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadmium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidify

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around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.

The design and labeling of the Stryker CRS addresses the risks associated with thermal injury to surrounding tissue, toxicity of fumes, and breakage of tip and fracture of bone during removal process. Additionally, data collected at the University of Michigan and Michigan State University demonstrated that the CRS does not raise any new safety issues when compared to other heat generating cement removal systems and it does not produce a greater amount of fumes than what is created when hand mixing bone cement. The CRS device is contraindicated for use in patients with unrestored fractures, severe osteoporosis, and a cement plug distal to a restriction within the medullary canal.

The Stryker CRS is equivalent to existing marketed products by companies such as Biomet, Inc. Intended use, method of extraction, and safety risks are all substantially equivalent.

The Stryker CRS does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker CRS is substantially equivalent to these existing devices.