Cleared Special

K010786 - ULNAR HEAD IMPLANT

K010786 is an FDA 510(k) clearance for ULNAR HEAD IMPLANT, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KXE cleared through the Special 510(k) pathway after a 27-day FDA review.

K010786 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
27d
Days
Class 2
Risk

K010786 is an FDA 510(k) clearance for the ULNAR HEAD IMPLANT. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 27 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 - K010786

510(k) Number K010786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date April 11, 2001
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 K010786.
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902 · Stuckenbrock Medizintechnik GmbH · Dec 2004
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
K033930 · Kapp Surgical Instrument, Inc. · Jul 2004
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · Wrightmedicaltechnologyinc · Feb 2002
ULNAR HEAD IMPLANT
K982268 · Avanta Orthopaedics, Inc. · Dec 1998
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K812053 · Dow Corning Corp. Healthcare Industries Materials · Aug 1981
ULNAR HEAD PROTHESIS
K790125 · Cutter Laboratories, Inc. · Feb 1979
K010786 · ULNAR HEAD IMPLANT
Download PDF FDA Summary Avanta Orthopaedics, …