Cleared Traditional

SPINAL PEDICLE SCREW, FIXATION, APPLIANCE (K952298) - 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.

Regulatory Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 39
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K952298.
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · Depuy, Inc. · Feb 1996
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626 · Synthes (Usa) · Aug 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · Synthes (Usa) · Aug 1995