Cleared Traditional

K942603 - ORTHOPAEDIC WIRES

K942603 is an FDA 510(k) clearance for ORTHOPAEDIC WIRES, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code LRN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K942603 · Acu Med, Inc. · Orthopedic device
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Nov 1994
Decision
161d
Days
Class 2
Risk

K942603 is an FDA 510(k) clearance for the ORTHOPAEDIC WIRES. Classified as Wire, Surgical (product code LRN), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on November 9, 1994 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K942603

510(k) Number K942603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1994
Decision Date November 09, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRN Device Classification - Class 2, Special Controls

Product Code LRN Wire, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LRN Wire, Surgical

Devices cleared under the same product code (LRN) and FDA review panel - the closest regulatory comparables to K942603.
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
K002755 · T. Korossurgical Instruments Corp. · Dec 2000
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · Bregma International Trading Company , Ltd. · Jul 1999
J-FX CERCLAGE SYSTEM
K971682 · Johnson & Johnson Professionals, Inc. · Jun 1997
TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)
K900926 · Howmedica Corp. · Apr 1990
SONGER WIRING SYSTEM
K892651 · Danek Medical, Inc. · Jul 1989