Cleared Traditional

K952298 - SPINAL PEDICLE SCREW, FIXATION, APPLIANCE

K952298 is an FDA 510(k) clearance for SPINAL PEDICLE SCREW, manufactured by J.B.S., S.A.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K952298

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.

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 254
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K952298.
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999 · Buckman Co., Inc. · Jan 1996
ISOLA SYSTEM
K952236 · Acromed Corp. · Jan 1996
SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
K953779 · Advanced Spine Fixation Systems, Inc. · Nov 1995
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
K953778 · Advanced Spine Fixation Systems, Inc. · Nov 1995
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · Sofamor Danek USA,Inc. · Oct 1995