Cleared Traditional

WARSAW ORTHOPEDIC POINTED REAMER (K870845) - FDA 510(k) Clearance

Class I Orthopedic device.

K870845 · Warsaw Orthopedic, Inc. · Orthopedic device
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Mar 1987
Decision
8d
Days
Class 1
Risk

K870845 is an FDA 510(k) clearance for the WARSAW ORTHOPEDIC POINTED REAMER. Classified as Reamer (product code HTO), Class I - General Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 11, 1987 after a review of 8 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

Submission Details

510(k) Number K870845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date March 11, 1987
Days to Decision 8 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 122d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTO Reamer
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.

Regulatory Peers - HTO Reamer

All 7
Devices cleared under the same product code (HTO) and FDA review panel - the closest regulatory comparables to K870845.
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · Synthes (Usa) · Dec 2001
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335 · Synthes (Usa) · Jun 2000
FLEXIBLE INTRAMEDULLARY REAMER
K954915 · Zimmer, Inc. · Dec 1995
C.C.F. FEMORAL DEBRIDEMENT PROBE
K790996 · Depuy, Inc. · Jun 1979
FLEXIBLE REAMER, GUIDE WIRE SYSTEM
K790307 · 3M Company · Feb 1979
HAND REAMERS
K770203 · Depuy, Inc. · Feb 1977