Cleared Traditional

K133363 - INTERBRIDGE INTERSPINOUS POSTERIOR FIXA...

K133363 is an FDA 510(k) clearance for INTERBRIDGE INTERSPINOUS POSTERIOR FIXA..., manufactured by Ldr Spine USA, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

FDA 510(k) Submission Details - K133363

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.

PEK Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K133363.
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · Spineart · Aug 2014
PFX SPINOUS PROCESS FIXATION SYSTEM
K132765 · Innovasis, Inc. · Jul 2014
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K133052 · Nuvasive, Inc. · Dec 2013
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · Globus Medical, Inc. · Nov 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · Nu Vasive, Incorporated · Nov 2013