Cleared Traditional

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (K933995) - FDA 510(k) Clearance

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

K933995 · Applied Osteo Systems, Inc. · Orthopedic device
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Jan 1995
Decision
528d
Days
Class 2
Risk

K933995 is an FDA 510(k) clearance for the TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION. 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 27, 1995 after a review of 528 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Applied Osteo Systems, Inc. devices

Submission Details

510(k) Number K933995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date January 27, 1995
Days to Decision 528 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
406d slower than avg
Panel avg: 122d · This submission: 528d
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 K933995.
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
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · Howmedica Corp. · Oct 1994
SYNTHES UNREAMED HUMERAL NAIL (URHN)
K933518 · Synthes (Usa) · Mar 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · Synthes (Usa) · Mar 1994