Cleared Traditional

K121482 - INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL...

K121482 is an FDA 510(k) clearance for INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL..., manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K121482 · Theken Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
102d
Days
Class 2
Risk

K121482 is an FDA 510(k) clearance for the INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Theken Spine, LLC (Medina, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 102 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. 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 Theken Spine, LLC devices

FDA 510(k) Submission Details - K121482

510(k) Number K121482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date August 28, 2012
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 413
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K121482.
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
K130169 · Depuy Mitek, A Johnson & Johnson Company · May 2013
STRYKER CROSSFLOW ARTHROSCOPY PUMP
K123441 · Stryker Endoscopy · Jan 2013
KYPHON EXPRESS II INFLATABLE BONE TAMPS
K123771 · Medtronic · Dec 2012
KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
K093471 · KARL STORZ Endoscopy-America, Inc. · Oct 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · Medtronic · Oct 2010
STRYKER ARTHROSCOPE
K093677 · Stryker Endoscopy · Mar 2010