Cleared Traditional

K920149 - OSTEO EX-FI-RE

K920149 is an FDA 510(k) clearance for OSTEO EX-FI-RE, manufactured by Osteo AG. The device is a Class 2 Orthopedic device with product code JEC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920149 · Osteo AG · Orthopedic device
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Apr 1992
Decision
90d
Days
Class 2
Risk

K920149 is an FDA 510(k) clearance for the OSTEO EX-FI-RE. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Osteo AG (Greenwood, US). The FDA issued a Cleared decision on April 9, 1992 after a review of 90 days - within the typical 510(k) review window.

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: 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 Osteo AG devices

FDA 510(k) Submission Details - K920149

510(k) Number K920149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1992
Decision Date April 09, 1992
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
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 - JEC Component, Traction, Invasive

All 56
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K920149.
PELVIC C-CLAMP
K922796 · Synthes (Usa) · Mar 1994
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP
K934698 · Howmedica Corp. · Feb 1994
HOWMEDICA MONOTUBE T-CONNECTOR
K936124 · Howmedica, Inc. · Feb 1994
ACE OPEN-BACK HALO RING
K914858 · Ace Medical Co. · Nov 1991
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO
K894959 · Alphatec Mfg., Inc. · Sep 1990
OLIVE K-WIRES
K903105 · Danek Medical, Inc. · Sep 1990