Cleared Traditional

K870844 - SCHULTZ PROSTHESIS COMPONENT INSERTER E...

K870844 is an FDA 510(k) clearance for SCHULTZ PROSTHESIS COMPONENT INSERTER E..., manufactured by Warsaw Orthopedic, Inc.. The device is a Class 1 Orthopedic device with product code HWB cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K870844 · Warsaw Orthopedic, Inc. · Orthopedic device
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Mar 1987
Decision
10d
Days
Class 1
Risk

K870844 is an FDA 510(k) clearance for the SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR. Classified as Extractor (product code HWB), Class I - General Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K870844

510(k) Number K870844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date March 13, 1987
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

HWB Device Classification - Class 1, General Controls

Product Code HWB Extractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.