Cleared Traditional

K904156 - ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/S...

K904156 is an FDA 510(k) clearance for ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/S..., manufactured by Origin Medsystems, Inc.. The device is a Class 2 Orthopedic device with product code LZV cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K904156 · Origin Medsystems, Inc. · Orthopedic device
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Nov 1990
Decision
81d
Days
Class 2
Risk

K904156 is an FDA 510(k) clearance for the ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS. Classified as System, Cement Removal Extraction (product code LZV), Class II - Special Controls.

Submitted by Origin Medsystems, Inc. (San Mateo, US). The FDA issued a Cleared decision on November 27, 1990 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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 Origin Medsystems, Inc. devices

FDA 510(k) Submission Details - K904156

510(k) Number K904156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1990
Decision Date November 27, 1990
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZV Device Classification - Class 2, Special Controls

Product Code LZV System, Cement Removal Extraction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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.