Cleared Traditional

K950999 - KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS

K950999 is an FDA 510(k) clearance for KSF POSTERIOR SPINGAL FIXATOR FOR SEVER..., manufactured by Buckman Co., Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K950999 · Buckman Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
328d
Days
Class 2
Risk

K950999 is an FDA 510(k) clearance for the KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Buckman Co., Inc. devices

FDA 510(k) Submission Details - K950999

510(k) Number K950999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date January 25, 1996
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
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 280
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K950999.
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · Depuy, Inc. · Feb 1996
SPINE FIXATION
K943827 · Danek Medical, Inc. · Feb 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 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