Cleared Traditional

K151268 - SPINAUT-V

K151268 is the FDA 510(k) clearance for SPINAUT-V by Imedicom Co., Ltd.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K151268 · Imedicom Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
308d
Days
Class 2
Risk

K151268 is an FDA 510(k) clearance for the SPINAUT-V, SPINAUT-S, SPINAUT-I. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Imedicom Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on March 16, 2016 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Imedicom Co., Ltd. devices

Submission Details

510(k) Number K151268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2015
Decision Date March 16, 2016
Days to Decision 308 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 365
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K151268.
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
K162062 · Stryker Corporation · Nov 2016
ULTRA Telescopes
K160249 · Olympus Winter & Ibe GmbH · Apr 2016
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
K151932 · Stryker Corporation · Mar 2016
AVAflex Vertebral Balloon System
K151125 · Care Fusion · Nov 2015
AVAmax Vertebral Balloon
K150523 · Care Fusion · Oct 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · Medtronic, Inc. · Jul 2015