Cleared Traditional

K954756 - FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM

K954756 is an FDA 510(k) clearance for FIXANO I.F.O (INTERLOCKING FLEXIBLE OST..., manufactured by Ferguson Medical. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K954756 · Ferguson Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
101d
Days
Class 2
Risk

K954756 is an FDA 510(k) clearance for the FIXANO I.F.O (INTERLOCKING FLEXIBLE OSTEOSYNTHESIS) SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Ferguson Medical devices

FDA 510(k) Submission Details - K954756

510(k) Number K954756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date January 25, 1996
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 468
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K954756.
ALTA CFX IM ROD SYSTEM
K960524 · Howmedica Corp. · Mar 1996
TIBIA ORTHONAIL
K955761 · Orthologic Corp. · Mar 1996
TI-6AL-7NB URTN
K932330 · Synthes (Usa) · Mar 1996
ALTA TIBIAL/HUMERAL ROD
K954554 · Howmedica Corp. · Dec 1995
SYNTHES FLEXNAIL
K953334 · Synthes (Usa) · Oct 1995
INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL
K952923 · Howmedica Corp. · Sep 1995