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Simplex P SpeedSet With Tobramycin Bone Cement

by Howmedica Osteonics Corp.

510(k) K063857

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 NumberK063857 Date26 Feb 2007ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
MBB
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Simplex P SpeedSet with Tobramycin is an antibiotic bone cement classified as a bone cement device. It is indicated for the fixation of prostheses to living bone during the second stage of a two-stage revision for total joint arthroplasty.

This device is manufactured by Howmedica Osteonics Corp. and has received FDA 510(k) clearance. It is regulated under 21 CFR 888.3027 and is categorized under the orthopedic medical specialty.

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See all devices from Howmedica Osteonics Corp. →

Questions

AI-generated answers, 24 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 primary clinical indication for Simplex P SpeedSet with Tobramycin?

    This device is specifically indicated for the fixation of prostheses to living bone. It is intended for use during the second stage of a two-stage revision procedure for total joint arthroplasty.

  • What type of medical device is this product?

    Simplex P SpeedSet with Tobramycin is classified as an antibiotic bone cement. It is regulated under 21 CFR 888.3027 within the orthopedic medical specialty.

  • Has this device received regulatory authorization?

    Yes, the device is manufactured by Howmedica Osteonics Corp. and has received FDA 510(k) clearance under the submission number K063857.