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OSCAR Orthosonics System for Cemented Arthroplasty Revision

by C.L. Mcintosh & Assoc., Inc. 510(k)

Active United States

510(k) K961725

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961725 Date1 Aug 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JDX
Device Class
Class II
Regulation
21 CFR Part 888.4580
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OSCAR Orthosonics System for Cemented Arthroplasty Revision is a Surgical Instrument, Sonic and Accessory/Attachment designed for the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision procedures. It employs ultrasonic technology to facilitate precise and controlled cement extraction, aiding in the preparation of the surgical site for revision implants.

This system is intended for use in orthopedic surgical settings and is supplied as a reusable device. It is classified under FDA regulation 888.4580 and received FDA 510(k) clearance under the Traditional pathway, with a decision date of August 1, 1996. The system includes multiple accessory components, each identified by specific registration numbers, and is intended for single-use applications per the manufacturer’s specifications.

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