Cleared Traditional

K982268 - ULNAR HEAD IMPLANT

K982268 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 Traditional 510(k) pathway after a 158-day FDA review.

K982268 · Avanta Orthopaedics, Inc. · Orthopedic device
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Dec 1998
Decision
158d
Days
Class 2
Risk

K982268 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 December 4, 1998 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3810 - 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. Standard predicate reliance. 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K982268

510(k) Number K982268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1998
Decision Date December 04, 1998
Days to Decision 158 days
Submission Type Traditional
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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 7
Devices cleared under the same product code (KXE) and FDA review panel - the closest regulatory comparables to K982268.
ASCENSION MUH
K052137 · Ascension Orthopedics, Inc. · Nov 2005
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · Wrightmedicaltechnologyinc · Feb 2002
ULNAR HEAD IMPLANT
K010786 · Avanta Orthopaedics, Inc. · Apr 2001
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