Cleared Traditional

K954856 - CANNULATED FEMORAL NAIL

K954856 is an FDA 510(k) clearance for CANNULATED FEMORAL NAIL, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code JDN cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K954856 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
137d
Days
Class 2
Risk

K954856 is an FDA 510(k) clearance for the CANNULATED FEMORAL NAIL. Classified as Implant, Fixation Device, Spinal (product code JDN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K954856

510(k) Number K954856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1995
Decision Date March 08, 1996
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDN Device Classification - Class 2, Special Controls

Product Code JDN Implant, Fixation Device, Spinal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - JDN Implant, Fixation Device, Spinal

Devices cleared under the same product code (JDN) and FDA review panel - the closest regulatory comparables to K954856.
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
K897141 · Stuart · Jun 1990
BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
K894184 · Biedermann Motech GmbH · Apr 1990
UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
K872715 · Roseburg SA · Dec 1987
NEW C-D SYSTEM FOR SPINAL SURGERY
K873977 · Sofamor Co. · Dec 1987
TOTAL SPINAL CORRECTION
K760649 · Depuy, Inc. · Oct 1976
K954856 · CANNULATED FEMORAL NAIL
Download PDF FDA Summary Synthes (Usa)