Cleared Traditional

K871287 - ORTHOPEDIC DRILL GUIDE

K871287 is an FDA 510(k) clearance for ORTHOPEDIC DRILL GUIDE, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K871287 · Orthopedic Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Apr 1987
Decision
15d
Days
Class 1
Risk

K871287 is an FDA 510(k) clearance for the ORTHOPEDIC DRILL GUIDE. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on April 15, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K871287

510(k) Number K871287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date April 15, 1987
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K871287.
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324 · Micro-Aire Surgical Instruments, Inc. · Feb 1988
1.1 COUPLERS AND 1.2 ADAPTERS
K872550 · Micro-Aire Surgical Instruments, Inc. · Jul 1987
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
K871891 · KARL STORZ Endoscopy-America, Inc. · Jun 1987
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · The Anspach Effort, Inc. · Nov 1986
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · Micro-Aire Surgical Instruments, Inc. · May 1985