Cleared Special

K121548 - SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

K121548 is an FDA 510(k) clearance for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), manufactured by Spine View, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 83-day FDA review.

K121548 · Spine View, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
83d
Days
Class 2
Risk

K121548 is an FDA 510(k) clearance for the SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Spine View, Inc. (Fremont, US). The FDA issued a Cleared decision on August 16, 2012 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121548

510(k) Number K121548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date August 16, 2012
Days to Decision 83 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 606
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K121548.
XTOOL
K122861 · Ouroboros Medical · Dec 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · Vertiflex, Inc. · Nov 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · Theken Spine, LLC · Aug 2012
ALTOMEC ARTHROSCOPE
K112548 · Altomec Endoscopy, Inc. · Aug 2012
ESPIN
K120553 · Nlt Spine, Ltd. · Aug 2012
ENSPIRE DISCECTOMY SYSTEM
K120680 · Spine View, Inc. · Jun 2012