Cleared Special

K023680 - BIOBUCK CEMENT RESTRICTOR

K023680 is an FDA 510(k) clearance for BIOBUCK CEMENT RESTRICTOR, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Special 510(k) pathway after a 18-day FDA review.

K023680 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
18d
Days
Class 2
Risk

K023680 is an FDA 510(k) clearance for the BIOBUCK CEMENT RESTRICTOR. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on November 19, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023680

510(k) Number K023680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date November 19, 2002
Days to Decision 18 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

LZN Device Classification - Class 2, Special Controls

Product Code LZN Cement Obturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZN Cement Obturator

All 36
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K023680.
Artisan Bone Plug, Universal Cement Restrictor
K220838 · Howmedica Osteonics, Dba Stryker Orthopaedics · May 2022
TORNIER CEMENT RESTRICTOR
K061824 · Tornier · Sep 2006
CEMSTOP CEMENT RESTRICTOR
K032685 · Teknimed, S.A. · Nov 2003
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · Kensey Nash Corp. · Sep 2001
SYNPLUG
K010840 · Isotis NV · Apr 2001
SHUTTLE STOP
K000587 · Isotis NV · May 2000
K023680 · BIOBUCK CEMENT RESTRICTOR
Download PDF FDA Summary Smith & Nephew, Inc.