Cleared Traditional

K962047 - TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

K962047 is the FDA 510(k) clearance for TITANIUM CANNULATED TIBIAL NAIL (TI CTN) by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K962047 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
57d
Days
Class 2
Risk

K962047 is an FDA 510(k) clearance for the TITANIUM CANNULATED TIBIAL NAIL (TI CTN). 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 July 24, 1996 after a review of 57 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 K962047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date July 24, 1996
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 K962047.
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
BONE FIXATION NAIL
K943855 · Acu Med, Inc. · Jul 1995
HAIG NAIL
K940736 · Howmedica Corp. · Sep 1994
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004 · Howmedica Corp. · Nov 1992