Cleared Traditional

K851339 - PRECISION HARVEST & INLAY INSTRUMENT SET

K851339 is an FDA 510(k) clearance for PRECISION HARVEST & INLAY INSTRUMENT SET, manufactured by Concept, Inc.. The device is a Class 1 Orthopedic device with product code HWK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K851339 · Concept, Inc. · Orthopedic device
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Jul 1985
Decision
90d
Days
Class 1
Risk

K851339 is an FDA 510(k) clearance for the PRECISION HARVEST & INLAY INSTRUMENT SET. Classified as Trephine (product code HWK), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K851339

510(k) Number K851339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1985
Decision Date July 02, 1985
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HWK Device Classification - Class 1, General Controls

Product Code HWK Trephine
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.