Cleared Traditional

K913949 - TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS

K913949 is an FDA 510(k) clearance for TRUE/FLEX HUMERUS, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K913949 · Applied Osteo Systems, Inc. · Orthopedic device
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Jan 1992
Decision
130d
Days
Class 2
Risk

K913949 is an FDA 510(k) clearance for the TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 130 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 Applied Osteo Systems, Inc. devices

FDA 510(k) Submission Details - K913949

510(k) Number K913949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date January 17, 1992
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 499
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K913949.
ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES
K922266 · Howmedica Corp. · Sep 1992
INTRAMEDULARY FIXATION ROD
K920666 · Acu Med, Inc. · Aug 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · Stryker Corp. · Mar 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · Stryker Corp. · Jan 1992
AIM TIBIAL NAIL
K911554 · Ace Medical Co. · Jul 1991
ALTA(R) PFX IM ROD
K903526 · Howmedica Corp. · Mar 1991