Cleared Traditional

TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY (K902264) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K902264 · Applied Osteo Systems, Inc. · Orthopedic device
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Jul 1990
Decision
52d
Days
Class 2
Risk

K902264 is an FDA 510(k) clearance for the TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Moraga, US). The FDA issued a Cleared decision on July 12, 1990 after a review of 52 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 Applied Osteo Systems, Inc. devices

Submission Details

510(k) Number K902264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date July 12, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 259
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K902264.
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · Stryker Corp. · Mar 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · Stryker Corp. · Jan 1992
ALTA(R) PFX IM ROD
K903526 · Howmedica Corp. · Mar 1991
ALTA HOLLOW TIBIAL RODS
K890936 · Howmedica Corp. · Jun 1989
ALTA NON-REAMED TIBIAL ROD
K884500 · Howmedica Corp. · Jan 1989
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · Depuy, Inc. · Dec 1988