Cleared Traditional

K880381 - TELOS DISTAL TARGETING DEVICE

K880381 is an FDA 510(k) clearance for TELOS DISTAL TARGETING DEVICE, manufactured by Austin Assoc.. The device is a Class 1 Orthopedic device with product code HXY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K880381 · Austin Assoc. · Orthopedic device
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Mar 1988
Decision
48d
Days
Class 1
Risk

K880381 is an FDA 510(k) clearance for the TELOS DISTAL TARGETING DEVICE. Classified as Brace, Drill (product code HXY), Class I - General Controls.

Submitted by Austin Assoc. (Fallston,, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 48 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.

FDA 510(k) Submission Details - K880381

510(k) Number K880381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1988
Decision Date March 15, 1988
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

HXY Device Classification - Class 1, General Controls

Product Code HXY Brace, Drill
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 - HXY Brace, Drill

Devices cleared under the same product code (HXY) and FDA review panel - the closest regulatory comparables to K880381.
BENDEREV DRILL GUIDE
K923776 · Neimark Labs, Inc. · Nov 1992
MITEK DRILL GUIDE
K892904 · Mitek Surgical Products, Inc. · Sep 1989
BONE SUTURE FIXATION DEVICE
K880264 · Orthopedic Systems, Inc. · Mar 1988
HASTING FINGER FIXATOR INSTRUMENTS
K880046 · Buckman Co., Inc. · Feb 1988
ANDREWS REMOTE CHUCK DRILL
K831043 · Orthopedic Systems, Inc. · Apr 1983
CEMENT EXTRACTOR DRILL
K770204 · Depuy, Inc. · Feb 1977
K880381 · TELOS DISTAL TARGETING DEVICE
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