Cleared Abbreviated

K983942 - INTRAMEDULLARY NAIL SYSTEM

K983942 is the FDA 510(k) clearance for INTRAMEDULLARY NAIL SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDS) cleared through the Abbreviated 510(k) pathway after a 29-day FDA review.

K983942 · Smith & Nephew, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
29d
Days
Class 2
Risk

K983942 is an FDA 510(k) clearance for the INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K983942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date December 04, 1998
Days to Decision 29 days
Submission Type Abbreviated
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K983942.
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · Howmedica Osteonics Corp. · Oct 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · Synthes (Usa) · Sep 1999
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · Smith & Nephew, Inc. · Jul 1998
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · Synthes (Usa) · Sep 1997
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047 · Synthes (Usa) · Jul 1996