Cleared Traditional

K060132 - SPINAL USA CEMENT RESTRICTOR SYSTEM

K060132 is an FDA 510(k) clearance for SPINAL USA CEMENT RESTRICTOR SYSTEM, manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K060132 · Spinal USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
57d
Days
Class 2
Risk

K060132 is an FDA 510(k) clearance for the SPINAL USA CEMENT RESTRICTOR SYSTEM. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Spinal USA (Brandon, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 57 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 Spinal USA devices

FDA 510(k) Submission Details - K060132

510(k) Number K060132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date March 16, 2006
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 34
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K060132.
Mectaplug PE II
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PEEK CEMENT RESTRICTOR X-BOX
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K033953 · Spineology, Inc. · Jul 2004
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp. · Nov 2003