Cleared Traditional

K123203 - MAXLOCK EXTREME SYSTEM MODEL MXL

K123203 is an FDA 510(k) clearance for MAXLOCK EXTREME SYSTEM MODEL MXL, manufactured by Orthohelix Surgical Designs, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K123203 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Dec 2012
Decision
63d
Days
Class 2
Risk

K123203 is an FDA 510(k) clearance for the MAXLOCK EXTREME SYSTEM MODEL MXL. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Medina, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 63 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.

View all Orthohelix Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K123203

510(k) Number K123203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date December 14, 2012
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123203.
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K123000 · Integra LifeSciences Corporation · Dec 2012
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K121495 · Aap Implantate AG · Dec 2012
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K122334 · Arthrosurface, Inc. · Nov 2012
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K120787 · Merete Medical GmbH · Nov 2012