Cleared Traditional

K051216 - HYDRALOK SYSTEM

K051216 is an FDA 510(k) clearance for HYDRALOK SYSTEM, manufactured by Altiva Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K051216 · Altiva Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
68d
Days
Class 2
Risk

K051216 is an FDA 510(k) clearance for the HYDRALOK SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Altiva Corp. (Charlotte, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Altiva Corp. devices

FDA 510(k) Submission Details - K051216

510(k) Number K051216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2005
Decision Date July 19, 2005
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 208
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K051216.
NUVASIVE SPHERX SYSTEM
K060225 · Nuvasive, Inc. · Apr 2006
GSS PEDICLE SCREW SYSTEM
K053573 · GS Medical Co., Ltd. · Mar 2006
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 2005
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K050471 · Solco Biomedical Co., Ltd. · May 2005
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
K043578 · Solco Biomedical Co., Ltd. · Mar 2005
STRYKER SPINE TRIO PS
K043180 · Stryker Spine · Mar 2005