Cleared Traditional

K033639 - ACUMED LOWER EXTREMITY CONGRUENT PLATE ...

K033639 is an FDA 510(k) clearance for ACUMED LOWER EXTREMITY CONGRUENT PLATE ..., manufactured by Acumed, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K033639 · Acumed, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
56d
Days
Class 2
Risk

K033639 is an FDA 510(k) clearance for the ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 56 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 Acumed, LLC devices

FDA 510(k) Submission Details - K033639

510(k) Number K033639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2003
Decision Date January 15, 2004
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K033639.
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
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BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp. · Dec 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc. · Dec 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · Stryker Endoscopy · Nov 2003