Cleared Traditional

K926465 - FEMORAL INTRAMEDULLARY RODS

K926465 is an FDA 510(k) clearance for FEMORAL INTRAMEDULLARY RODS, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K926465 · Applied Osteo Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
244d
Days
Class 2
Risk

K926465 is an FDA 510(k) clearance for the FEMORAL INTRAMEDULLARY RODS. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 244 days - an extended review 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: 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.

View all Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K926465

510(k) Number K926465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date August 25, 1993
Days to Decision 244 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 122d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K926465.
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047 · Synthes (Usa) · Jul 1996
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
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992