Cleared Traditional

K890989 - DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR

K890989 is an FDA 510(k) clearance for DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR, manufactured by Origin Medsystems, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 401-day FDA review.

K890989 · Origin Medsystems, Inc. · Orthopedic device
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Apr 1990
Decision
401d
Days
Class 2
Risk

K890989 is an FDA 510(k) clearance for the DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (San Mateo, US). The FDA issued a Cleared decision on April 5, 1990 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K890989

510(k) Number K890989 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 28, 1989
Decision Date April 05, 1990
Days to Decision 401 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 122d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K890989.
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990
JEWETT HIP NAIL
K903251 · Onyx Medical Corp. · Jul 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584 · Howmedica Corp. · Apr 1990
INTRAMEDULLARY HIP SCREW
K895241 · Richards Medical Co., Inc. · Jan 1990
DANEK WRIST FIXATOR
K891066 · Danek Medical, Inc. · Aug 1989
GAMMA LOCKING NAIL
K893639 · Howmedica Corp. · Aug 1989