Cleared Traditional

K922195 - OSTEO FEMORAL NAIL

K922195 is an FDA 510(k) clearance for OSTEO FEMORAL NAIL, manufactured by Osteo AG. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K922195 · Osteo AG · Orthopedic device
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Jul 1992
Decision
73d
Days
Class 2
Risk

K922195 is an FDA 510(k) clearance for the OSTEO FEMORAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Osteo AG (Greenwood, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 73 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 Osteo AG devices

FDA 510(k) Submission Details - K922195

510(k) Number K922195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date July 23, 1992
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 466
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K922195.
SYNTHES TITANIUM UNREAMED FEMORAL NAIL
K923597 · Synthes (Usa) · Jan 1993
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