Cleared Traditional

K915613 - BONE SCREW 3.5 MM

K915613 is the FDA 510(k) clearance for BONE SCREW 3.5 MM by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K915613 · Acu Med, Inc. · Orthopedic device
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Feb 1992
Decision
59d
Days
Class 2
Risk

K915613 is an FDA 510(k) clearance for the BONE SCREW 3.5 MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 13, 1992 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Acu Med, Inc. devices

Submission Details

510(k) Number K915613 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 16, 1991
Decision Date February 13, 1992
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 562
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K915613.
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992
CONCEPT ENDOSTEAL FIXATION DEVICE
K912640 · Concept, Inc. · May 1992
CORTICAL BONE SCREW
K915448 · Dow Corning Wright · Feb 1992
UNIVERSAL COMPRESION SCREW
K915124 · Howmedica Corp. · Feb 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210 · Depuy, Inc. · Jan 1992
OREGON FIXATION SCREW
K910976 · Acu Med, Inc. · Jan 1992