Cleared Traditional

K051836 - SKELITE RESORBABLE CEMENT RESTRICTOR

K051836 is an FDA 510(k) clearance for SKELITE RESORBABLE CEMENT RESTRICTOR, manufactured by Millenium Biologix, Inc.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K051836 · Millenium Biologix, Inc. · Orthopedic device
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Nov 2005
Decision
138d
Days
Class 2
Risk

K051836 is an FDA 510(k) clearance for the SKELITE RESORBABLE CEMENT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Millenium Biologix, Inc. (West Cadwell, US). The FDA issued a Cleared decision on November 21, 2005 after a review of 138 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 Millenium Biologix, Inc. devices

FDA 510(k) Submission Details - K051836

510(k) Number K051836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 06, 2005
Decision Date November 21, 2005
Days to Decision 138 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 122d · This submission: 138d
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 38
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K051836.
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · Life Spine · Jul 2006
LIFE SPINE CEMENT RESTRICTOR
K060247 · Life Spine · May 2006
SPINAL USA CEMENT RESTRICTOR SYSTEM
K060132 · Spinal USA · Mar 2006
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · Amedica Corp. · Apr 2005
PEEK CEMENT RESTRICTOR X-BOX
K041583 · Innovasis, Inc. · Jul 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · Spineology, Inc. · Jul 2004