Cleared Traditional

K060247 - LIFE SPINE CEMENT RESTRICTOR

K060247 is an FDA 510(k) clearance for LIFE SPINE CEMENT RESTRICTOR, manufactured by Life Spine. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K060247

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.

JDK Device Classification - Class 2, Special Controls

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 41
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
KMI CEMENT RESTRICTOR IMPLANT
K061465 · Kinetikos Medical, Inc. · Oct 2006
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · Life Spine · Jul 2006
SPINAL USA CEMENT RESTRICTOR SYSTEM
K060132 · Spinal USA · Mar 2006
INTERBODY INNOVATIONS CEMENT RESTRICTOR
K051371 · Interbody Innovations, Llp · Dec 2005
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836 · Millenium Biologix, Inc. · Nov 2005