Cleared Traditional

K863447 - STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II

K863447 is an FDA 510(k) clearance for STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 S..., manufactured by Stryker Corp.. The device is a Class 1 General & Plastic Surgery device with product code GET cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K863447 · Stryker Corp. · General & Plastic Surgery device
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Sep 1986
Decision
21d
Days
Class 1
Risk

K863447 is an FDA 510(k) clearance for the STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery device 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 Stryker Corp. devices

FDA 510(k) Submission Details - K863447

510(k) Number K863447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1986
Decision Date September 29, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

GET Device Classification - Class 1, General Controls

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
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 - GET Motor, Surgical Instrument, Pneumatic Powered

All 10
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