Cleared Special

K120680 - ENSPIRE DISCECTOMY SYSTEM

K120680 is an FDA 510(k) clearance for ENSPIRE DISCECTOMY SYSTEM, 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 112-day FDA review.

K120680 · Spine View, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
112d
Days
Class 2
Risk

K120680 is an FDA 510(k) clearance for the ENSPIRE DISCECTOMY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Spine View, Inc. (Fremont, US). The FDA issued a Cleared decision on June 26, 2012 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K120680

510(k) Number K120680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2012
Decision Date June 26, 2012
Days to Decision 112 days
Submission Type Special
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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 K120680.
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K121548 · Spine View, Inc. · Aug 2012
ALTOMEC ARTHROSCOPE
K112548 · Altomec Endoscopy, Inc. · Aug 2012
ESPIN
K120553 · Nlt Spine, Ltd. · Aug 2012
TRANSCORP SPINAL ACCESS SYSTEM
K113352 · Transcorp, Inc. · Apr 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K113362 · Spine View, Inc. · Feb 2012
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
K113028 · Medisiss · Dec 2011