Cleared Traditional

K952298 - SPINAL PEDICLE SCREW, FIXATION, APPLIANCE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952298 · J.B.S., S.A. · Orthopedic device
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Dec 1995
Decision
211d
Days
Class 2
Risk

K952298 is an FDA 510(k) clearance for the SPINAL PEDICLE SCREW, FIXATION, APPLIANCE. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by J.B.S., S.A. (Foster City, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all J.B.S., S.A. devices

Submission Details

510(k) Number K952298 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 16, 1995
Decision Date December 13, 1995
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.