Cleared Special

K984353 - OSTEO 9MM IC TIBIAL NAIL

K984353 is an FDA 510(k) clearance for OSTEO 9MM IC TIBIAL NAIL, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 9-day FDA review.

K984353 · Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
9d
Days
Class 2
Risk

K984353 is an FDA 510(k) clearance for the OSTEO 9MM IC TIBIAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 9 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K984353

510(k) Number K984353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date December 16, 1998
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
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 475
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K984353.
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
K984543 · Syntec Scientific Corp. · Mar 1999
ZETA MULTIZONE LOCKING NAIL SYSTEM
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MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
K990120 · Depuy Ace Medical Co. · Feb 1999
HOLLAND FEMORAL NAIL SYSTEM
K983641 · Biomet, Inc. · Dec 1998
ZETA MULTIZONE LOCKING NAIL SYSTEM
K982958 · Howmedica Corp. · Nov 1998
G/K SFN AND STN LOCKING NAILS
K983358 · Howmedica, Inc. · Nov 1998