Cleared Special

K050699 - MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004

K050699 is an FDA 510(k) clearance for MODIFICATION TO: VENTED CEMENT RESTRICTOR, manufactured by Amedica Corp.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Special 510(k) pathway after a 28-day FDA review.

K050699 · Amedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
28d
Days
Class 2
Risk

K050699 is an FDA 510(k) clearance for the MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Amedica Corp. (Salt Lake City, US). The FDA issued a Cleared decision on April 15, 2005 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Amedica Corp. devices

FDA 510(k) Submission Details - K050699

510(k) Number K050699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date April 15, 2005
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K050699.
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K033953 · Spineology, Inc. · Jul 2004
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp. · Nov 2003