Cleared Special

K111001 - STERILE STORM (R) OPERATING KIT

K111001 is an FDA 510(k) clearance for STERILE STORM OPERATING KIT, manufactured by Intelligent Orthopaedics, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 36-day FDA review.

K111001 · Intelligent Orthopaedics, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
36d
Days
Class 2
Risk

K111001 is an FDA 510(k) clearance for the STERILE STORM (R) OPERATING KIT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Intelligent Orthopaedics, Ltd. (Stoke On Trent, Staffordshire, GB). The FDA issued a Cleared decision on May 17, 2011 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Low regulatory complexity profile. 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 - K111001

510(k) Number K111001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2011
Decision Date May 17, 2011
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1057
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K111001.
PRO FIXATION SYSTEM
K110538 · Synovis Orthopedic & Woundcare · Jul 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658 · Medartis AG · Jun 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · Synthes USA Products, LLC · May 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc · May 2011
LATARJET CORTICAL SCREW SET
K110763 · T.A.G. Medical Products Corporation, Ltd. · Apr 2011
LOW PROFILE SCREWS
K103705 · Arthrex, Inc. · Mar 2011
K111001 · STERILE STORM (R) OPERATING KIT
Download PDF FDA Summary Intelligent Orthopaed…