OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

K961725 · C.L. Mcintosh & Assoc., Inc. · JDX · Aug 1, 1996 · Orthopedic

Device Facts

• Record ID: K961725
• Device Name: OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
• Applicant: C.L. Mcintosh & Assoc., Inc.
• Product Code: JDX · Orthopedic
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

Device Story

Ultrasonic surgical instrument for PMMA bone cement removal during arthroplasty revision; consists of power module, handpiece, and cement removal probes. Ultrasonic energy generated by power module transmitted through probes to fragment/remove cement. Used in clinical/OR settings by surgeons. Benefits include efficient cement removal during revision procedures. System includes ultrasonic cleaning component for probe reprocessing.

Clinical Evidence

Bench testing performed addressing temperature rise in bone, bone damage from contact, reprocessing validation, electromagnetic compatibility, electrical safety, and sterilization validation. Clinical experience mentioned as part of safety/effectiveness evaluation. No specific clinical trial metrics provided.

Technological Characteristics

Ultrasonic energy source; probes constructed of Ti-6Al-4V titanium alloy; system includes three independent power modules mounted on a cart; includes ultrasonic cleaning system for probe reprocessing.

Indications for Use

Indicated for patients undergoing arthroplasty revision requiring removal of polymethylmethacrylate (PMMA) bone cement.

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.

Predicate Devices

• Advanced Osseous Technologies System 10 Model 100 Surgical System (K900003)
• Cooper Lasersonics CUSA System 200M (K864983)

Submission Summary (Full Text)

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K961725
AUG - 1 1996
AUG - 2 1996

# 510(k) Summary

## OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

Common/Classification Name: Sonic surgical instrument, 21 CFR 888.4580

Sponsor:
Orthosonics, Ltd.
Bremridge Farm
Ashburton
Devon TQ137JX
UK
[phone]
[phone]

Contact: Dr. Michael J. R. Young

Prepared: May 1, 1996

## A. LEGALLY MARKETED PREDICATE DEVICES

The OSCAR Orthosonics Ultrasonics Cement Removal System is substantially equivalent to the Advanced Osseous Technologies System 10 Model 100 Surgical System (K900003), and is similar to the Cooper Lasersonics CUSA System 200M (K864983).

## B. DEVICE DESCRIPTION

The OSCAR Orthosonics Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, a set of cement removal probes, and an ultrasonic cleaning system for part of the reprocessing procedures for reuse of the probes. Three independent power modules are included in each device and these are mounted in a cart for ease of use.

## C. INTENDED USE

The OSCAR Orthosonics System for Cemented Arthroplasty Revision is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

## D. TECHNOLOGICAL CHARACTERISTICS

The OSCAR Orthosonics Ultrasonic Cement Removal System has the same technological characteristics as the predicate device. The energy

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source is ultrasonic for both, and both have probes made of the titanium alloy Ti-6Al-4V.

## E. TESTING

Orthosonics carried out testing to address the following issues:

(1) temperature rise in bone during OSCAR procedures,
(2) damage to bone from direct contact,
(3) clinical experience,
(4) reprocessing probes for use on the next patient,
(5) electromagnetic compatibility,
(6) electrical safety, and
(7) validation of sterilization recommendations.

The results from all of these tests supported the safety and effectiveness of the Orthosonics OSCAR device and demonstrate that the Orthosonics OSCAR is substantially equivalent to the predicate devices.

## F. CONCLUSIONS

The Orthosonics OSCAR device has the same intended use and target population as the predicate devices. Orthosonics has demonstrated through its performance tests on the OSCAR device and its comparison of OSCAR characteristics with those of the predicate device that the OSCAR device is substantially equivalent to the predicate device.

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