Cleared Traditional

K100354 - PRIMAL OK INTERSPINOUS FUSION SYSTEM

K100354 is an FDA 510(k) clearance for PRIMAL OK INTERSPINOUS FUSION SYSTEM, manufactured by Osteomed LP. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K100354 · Osteomed LP · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
186d
Days
Class 2
Risk

K100354 is an FDA 510(k) clearance for the PRIMAL OK INTERSPINOUS FUSION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Osteomed LP (Chesterland, US). The FDA issued a Cleared decision on August 17, 2010 after a review of 186 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Osteomed LP devices

FDA 510(k) Submission Details - K100354

510(k) Number K100354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date August 17, 2010
Days to Decision 186 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
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K100354.
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · Pioneer Surgical Technology · Oct 2010
CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K102020 · Spinefrontier, Inc. · Sep 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · Nuvasive, Inc. · Jun 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685 · Alphatec Spine, Inc. · Jun 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · Lanx, Inc. · Apr 2010