Cleared Special

MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE (K990120) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K990120 · Depuy Ace Medical Co. · Orthopedic device
Download Printable Device Report (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.

View all Depuy Ace Medical Co. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K990120.
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · Howmedica Osteonics Corp. · Nov 1999
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
K992063 · Howmedica Osteonics Corp. · Sep 1999
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
K990152 · Howmedica Osteonics Corp. · Mar 1999
OSTEO 9MM IC TIBIAL NAIL
K984353 · Osteonics Corp. · Dec 1998
HOLLAND FEMORAL NAIL SYSTEM
K983641 · Biomet, Inc. · Dec 1998
ZETA MULTIZONE LOCKING NAIL SYSTEM
K982958 · Howmedica Corp. · Nov 1998