Cleared Traditional

K122845 - ES2 SPINAL SYSTEM MODEL 48280XXXX

K122845 is an FDA 510(k) clearance for ES2 SPINAL SYSTEM MODEL 48280XXXX, manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K122845 · Stryker Spine · Orthopedic device
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Dec 2012
Decision
81d
Days
Class 2
Risk

K122845 is an FDA 510(k) clearance for the ES2 SPINAL SYSTEM MODEL 48280XXXX. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Spine devices

FDA 510(k) Submission Details - K122845

510(k) Number K122845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2012
Decision Date December 07, 2012
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K122845.
MEDYSSEY CANNULATED PEDICLE SCREW
K121670 · Medyssey Co, Ltd. · Jan 2013
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · Seaspine, Inc. · Dec 2012
S4 SPINAL SYSTEM
K123352 · Aesculap Implant Systems, Inc. · Dec 2012
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
K122901 · Orthofix · Dec 2012
POLARIS SPINAL SYSTEM - BALLISTA II RODS
K123451 · Biomet Spine (Aka Ebi, LLC) · Dec 2012
VICEROY SPINAL SYSTEM
K122229 · Torrey Spine · Nov 2012