Cleared Traditional

K133061 - ESPIN SYSTEM

K133061 is an FDA 510(k) clearance for ESPIN SYSTEM, manufactured by Nlt Spine, Ltd.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K133061 · Nlt Spine, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
61d
Days
Class 2
Risk

K133061 is an FDA 510(k) clearance for the ESPIN SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Nlt Spine, Ltd. (Washington, US). The FDA issued a Cleared decision on November 27, 2013 after a review of 61 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. 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.

FDA 510(k) Submission Details - K133061

510(k) Number K133061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date November 27, 2013
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 K133061.
MITEK ARTHROSCOPES
K133941 · Medos International SARL · Apr 2014
DISCOSCOPES, CERVICAL ENDOSCOPES
K130778 · Rz Medizintechnik GmbH · Apr 2014
OSI Q SYSTEM ARTHROSCOPES
K133018 · Orthopedic Sciences, Inc. · Feb 2014
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
K132883 · Hemodia Sas · Nov 2013
AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
K131820 · Care Fusion · Oct 2013
AVAFLEX VERTEBRAL BALLOON SYSTEM
K131824 · Care Fusion · Oct 2013