Cleared Traditional

K992348 - SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (...

K992348 is the FDA 510(k) clearance for SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K992348 · Synthes (Usa) · Orthopedic device
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Sep 1999
Decision
71d
Days
Class 2
Risk

K992348 is an FDA 510(k) clearance for the SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN). Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 71 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K992348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1999
Decision Date September 23, 1999
Days to Decision 71 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K992348.
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · Howmedica Osteonics Corp. · Oct 1999
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · Smith & Nephew, Inc. · Dec 1998
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