Cleared Special

K061146 - SBI ULNAR HEAD IMPLANT

K061146 is an FDA 510(k) clearance for SBI ULNAR HEAD IMPLANT, manufactured by Small Bone Innovations, Inc.. The device is a Class 2 Orthopedic device with product code KXE cleared through the Special 510(k) pathway after a 85-day FDA review.

K061146 · Small Bone Innovations, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
85d
Days
Class 2
Risk

K061146 is an FDA 510(k) clearance for the SBI ULNAR HEAD IMPLANT. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on July 19, 2006 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3810 - 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 - K061146

510(k) Number K061146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2006
Decision Date July 19, 2006
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

KXE Device Classification - Class 2, Special Controls

Product Code KXE Prosthesis, Wrist, Hemi-, Ulnar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3810
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 - KXE Prosthesis, Wrist, Hemi-, Ulnar

All 15
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K061146.
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481 · Ascension Orthopedic · Apr 2012
ISOELASTICU
K081025 · Remi Sciences, Inc. · Nov 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
K082839 · Aptis Medical, LLC · Oct 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
K053119 · Aptis Medical, LLC · Dec 2005
ASCENSION MUH
K052137 · Ascension Orthopedics, Inc. · Nov 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K040497 · Aptis Medical, LLC · Jan 2005