Cleared Special

K990120 - MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE

K990120 is an FDA 510(k) clearance for MODIFICATION OF DEPUY ACE TIMAX MEDIAL ..., manufactured by Depuy Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 19-day FDA review.

K990120 · Depuy Ace Medical Co. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
19d
Days
Class 2
Risk

K990120 is an FDA 510(k) clearance for the MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Depuy Ace Medical Co. (El Segundo, US). The FDA issued a Cleared decision on February 1, 1999 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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.

FDA 510(k) Submission Details - K990120

510(k) Number K990120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date February 01, 1999
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 521
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K990120.
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K990120 · MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
Download PDF FDA Summary Depuy Ace Medical Co.