Cleared Traditional

K961027 - ORTHOFIX TIBIAL NAILING SYSTEM

K961027 is an FDA 510(k) clearance for ORTHOFIX TIBIAL NAILING SYSTEM, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K961027 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
55d
Days
Class 2
Risk

K961027 is an FDA 510(k) clearance for the ORTHOFIX TIBIAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthofix, Inc. (Rockville, US). The FDA issued a Cleared decision on May 8, 1996 after a review of 55 days - a notably fast clearance cycle.

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: 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 Orthofix, Inc. devices

FDA 510(k) Submission Details - K961027

510(k) Number K961027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date May 08, 1996
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K961027.
SUPRACONDYLAR INTRAMEDULLARY NAIL
K962561 · Zimmer, Inc. · Sep 1996
EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
K962553 · Biodynamic Technologies, Inc. · Aug 1996
POLARUS AF ROD
K962091 · Acu Med, Inc. · Jul 1996
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