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Consensus Bipolar System

by U.S. Medical Products, Inc.

510(k) K922560

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922560 Date11 Sep 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Consensus(Tm) Bipolar System
510(k) Number
FDA Product Code
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Consensus Bipolar System is an orthopedic device intended for use in hip joint femoral (hemi-hip) applications. It is a two-part prosthesis designed to replace the head and neck of the femur, available in metal/polymer configurations and intended for either cemented or uncemented implantation.

Supplied by U.S. Medical Products, Inc., the device received FDA 510(k) clearance under K922560 on September 11, 1992, and is classified under product code KWY. It is provided as a sterile, single-use implant for surgical use in orthopedic settings, with no indication of MRI safety or reusability specified in the data.

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Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Consensus Bipolar System used for?

    The Consensus Bipolar System is intended for use in hip joint femoral (hemi-hip) applications, designed to replace the head and neck of the femur in orthopedic surgery.

  • Is the Consensus Bipolar System sterile and single-use?

    Yes, the device is provided as a sterile, single-use implant for surgical use, as specified in the device data, and is not indicated for reuse.

  • How was the Consensus Bipolar System cleared for market?

    The device received FDA 510(k) clearance under submission K922560 on September 11, 1992, based on a determination of substantial equivalence to a predicate device.