Cleared Traditional

K033145 - HOFFMANN II PELVIC CLAMP

K033145 is an FDA 510(k) clearance for HOFFMANN II PELVIC CLAMP, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K033145 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
36d
Days
Class 2
Risk

K033145 is an FDA 510(k) clearance for the HOFFMANN II PELVIC CLAMP. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 5, 2003 after a review of 36 days - a notably fast clearance 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: 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 - K033145

510(k) Number K033145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date November 05, 2003
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXT Device Classification - Class 2, Special Controls

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 56
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K033145.
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
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CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
K032169 · Cyberorthology, Inc. · Sep 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973 · Synthes (Usa) · Sep 2003
K033145 · HOFFMANN II PELVIC CLAMP
Download PDF FDA Summary Howmedica Osteonics C…