Cleared Traditional

K133363 - INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM (FDA 510(k) Clearance)

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

K133363 · Ldr Spine USA, Inc. · Orthopedic device
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Mar 2014
Decision
126d
Days
Class 2
Risk

K133363 is an FDA 510(k) clearance for the INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Ldr Spine USA, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on March 7, 2014 after a review of 126 days - within the typical 510(k) review window.

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 Ldr Spine USA, Inc. devices

Submission Details

510(k) Number K133363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date March 07, 2014
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEK Spinous Process Plate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.
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 - PEK Spinous Process Plate

All 47
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K133363.
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primaLOK™ SP Interspinous Fusion System
K231807 · Wenzel Spine, Inc. · Aug 2023