Cleared Traditional

K122134 - FLEXLITE CAMERA

K122134 is an FDA 510(k) clearance for FLEXLITE CAMERA, manufactured by Spine View, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K122134 · Spine View, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
162d
Days
Class 2
Risk

K122134 is an FDA 510(k) clearance for the FLEXLITE CAMERA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Spine View, Inc. (Fremont, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 162 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

FDA 510(k) Submission Details - K122134

510(k) Number K122134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2012
Decision Date December 27, 2012
Days to Decision 162 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
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K122134.
ESPIN
K130057 · Nlt Spine, Ltd. · Feb 2013
STRYKER CROSSFLOW ARTHROSCOPY PUMP
K123441 · Stryker Endoscopy · Jan 2013
ASAP MUITISCOPE
K121261 · Asap Endoscopic Products GmbH · Jan 2013
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · Medtronic · Dec 2012
XTOOL
K122861 · Ouroboros Medical · Dec 2012
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · Vertiflex, Inc. · Nov 2012