Cleared Traditional

K013616 - POLARUS CAP SCREW

K013616 is the FDA 510(k) clearance for POLARUS CAP SCREW by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K013616 · Acu Med, Inc. · Orthopedic device
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Dec 2001
Decision
44d
Days
Class 2
Risk

K013616 is an FDA 510(k) clearance for the POLARUS CAP SCREW. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 K013616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date December 19, 2001
Days to Decision 44 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K013616.
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · Biomet Orthopedics, Inc. · Feb 2002
T2 FEMORAL NAIL SYSTEM
K014220 · Howmedica Osteonics Corp. · Jan 2002
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc. · Dec 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc. · Dec 2001
LONG LENGTH DYAX NAIL
K013468 · Howmedica Osteonics Corp. · Nov 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · Howmedica Osteonics Corp. · Nov 2001