Cleared Traditional

K060247 - LIFE SPINE CEMENT RESTRICTOR

K060247 is the FDA 510(k) clearance for LIFE SPINE CEMENT RESTRICTOR by Life Spine. It is a Class 2 Orthopedic device (product code JDK) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K060247 · Life Spine · Orthopedic device
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May 2006
Decision
100d
Days
Class 2
Risk

K060247 is an FDA 510(k) clearance for the LIFE SPINE CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on May 11, 2006 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Spine devices

Submission Details

510(k) Number K060247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 31, 2006
Decision Date May 11, 2006
Days to Decision 100 days
Submission Type Traditional
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
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDK Prosthesis, Hip, Cement Restrictor
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 - JDK Prosthesis, Hip, Cement Restrictor

All 23
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K060247.
Mectaplug PE II
K210062 · Medacta International S.A. · Apr 2021
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · Life Spine · Jul 2006
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · Spineology, Inc. · Jul 2004
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp. · Nov 2003
NUVASIVE CEMENT RESTRICTOR
K032180 · Nuvasive, Inc. · Oct 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · Interpore Cross Intl. · Aug 2003