Cleared Special

K113084 - RENOVIS CANNULATED SCREW SYSTEM

K113084 is an FDA 510(k) clearance for RENOVIS CANNULATED SCREW SYSTEM, manufactured by Renovis Surgical Technologies, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 52-day FDA review.

K113084 · Renovis Surgical Technologies, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
52d
Days
Class 2
Risk

K113084 is an FDA 510(k) clearance for the RENOVIS CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, LLC (Ashland, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 52 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 - K113084

510(k) Number K113084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2011
Decision Date December 09, 2011
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 1044
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K113084.
HEADLESS COMPRESSION SCREW
K112672 · Skeletal Dynamics, LLC · Dec 2011
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
K112658 · Osteospring Medical, Inc. · Dec 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011
DISCO SUBTALAR IMPLANT
K111834 · Trilliant Surgical, Ltd. · Dec 2011
SYNTHES CORTICAL SCREWS
K112583 · Synthes USA Products, LLC · Dec 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908 · Biomet Microfixation, Inc. · Nov 2011