Cleared Traditional

K000587 - SHUTTLE STOP

K000587 is an FDA 510(k) clearance for SHUTTLE STOP, manufactured by Isotis NV. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K000587 · Isotis NV · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
72d
Days
Class 2
Risk

K000587 is an FDA 510(k) clearance for the SHUTTLE STOP. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Isotis NV (North Attleboro, US). The FDA issued a Cleared decision on May 4, 2000 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Isotis NV devices

FDA 510(k) Submission Details - K000587

510(k) Number K000587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date May 04, 2000
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 23
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K000587.
TORNIER CEMENT RESTRICTOR
K061824 · Tornier · Sep 2006
BIOBUCK CEMENT RESTRICTOR
K023680 · Smith & Nephew, Inc. · Nov 2002
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · Kensey Nash Corp. · Sep 2001
CEMSTOP CEMENT RESTRICTOR
K993841 · Encore Orthopedics, Inc. · May 2000
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · Howmedica Osteonics Corp. · Aug 1999
LINK CEMENT PLUG
K972411 · Turnkey Intergration USA, Inc. · Aug 1997