Cleared Traditional

TRUE/FLEX TIBIAL RODS WITH CAP (K912710) - FDA 510(k) Clearance

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

K912710 · Applied Osteo Systems, Inc. · Orthopedic device
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Oct 1991
Decision
118d
Days
Class 2
Risk

K912710 is an FDA 510(k) clearance for the TRUE/FLEX TIBIAL RODS WITH CAP. 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 October 15, 1991 after a review of 118 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

Submission Details

510(k) Number K912710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1991
Decision Date October 15, 1991
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K912710.
ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES
K922266 · Howmedica Corp. · Sep 1992
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