Cleared Traditional

K970378 - STRYKER 2115 REPLACEMENT BATTERY (2115) (FDA 510(k) Clearance)

Class I Orthopedic device.

K970378 · Implant Resource, Inc. · Orthopedic device
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Apr 1997
Decision
89d
Days
Class 1
Risk

K970378 is an FDA 510(k) clearance for the STRYKER 2115 REPLACEMENT BATTERY (2115). Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Implant Resource, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 89 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 Implant Resource, Inc. devices

Submission Details

510(k) Number K970378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date April 30, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And 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.