Cleared Traditional

K922194 - OSTEO STEINMANN PIN

K922194 is an FDA 510(k) clearance for OSTEO STEINMANN PIN, manufactured by Osteo AG. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K922194 · Osteo AG · Orthopedic device
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Jul 1992
Decision
73d
Days
Class 2
Risk

K922194 is an FDA 510(k) clearance for the OSTEO STEINMANN PIN. Classified as Pin, Fixation, Smooth (product code HTY), 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 888.3040 - 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 - K922194

510(k) Number K922194 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.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 173
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K922194.
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993
OTI ORTHOPEDIC FASTENER SYSTEM
K925301 · Osteo Technology, Inc. · Mar 1993
STEINMAN PIN
K905337 · O'Tec Corp. · Dec 1990
RUSH PIN
K905341 · O'Tec Corp. · Dec 1990
K-WIRE
K905345 · O'Tec Corp. · Dec 1990