Cleared Traditional

K972411 - LINK CEMENT PLUG

K972411 is an FDA 510(k) clearance for LINK CEMENT PLUG, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K972411 · Turnkey Intergration USA, Inc. · Orthopedic device
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Aug 1997
Decision
64d
Days
Class 2
Risk

K972411 is an FDA 510(k) clearance for the LINK CEMENT PLUG. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Denville, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 64 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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K972411

510(k) Number K972411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date August 29, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 19
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K972411.
BIOBUCK CEMENT RESTRICTOR
K023680 · Smith & Nephew, Inc. · Nov 2002
CEMSTOP CEMENT RESTRICTOR
K993841 · Encore Orthopedics, Inc. · May 2000
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · Howmedica Osteonics Corp. · Aug 1999
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · Osteonics Corp. · May 1997
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · Depuy, Inc. · Jul 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995