Cleared Traditional

K994041 - TORNIER BIPOLAR RADIAL HEAD PROSTHESIS

K994041 is an FDA 510(k) clearance for TORNIER BIPOLAR RADIAL HEAD PROSTHESIS, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code KWI cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K994041 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
276d
Days
Class 2
Risk

K994041 is an FDA 510(k) clearance for the TORNIER BIPOLAR RADIAL HEAD PROSTHESIS. Classified as Prosthesis, Elbow, Hemi-, Radial, Polymer (product code KWI), Class II - Special Controls.

Submitted by Tornier, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on August 31, 2000 after a review of 276 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3170 - 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 Tornier, Inc. devices

FDA 510(k) Submission Details - K994041

510(k) Number K994041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1999
Decision Date August 31, 2000
Days to Decision 276 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
154d slower than avg
Panel avg: 122d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWI Device Classification - Class 2, Special Controls

Product Code KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3170
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 - KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

All 20
Devices cleared under the same product code (KWI) and FDA review panel - the closest regulatory comparables to K994041.
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · Biomet, Inc. · Jun 2004
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · Wrightmedicaltechnologyinc · Aug 2003
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · Biomet, Inc. · Jan 2002
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · Howmedica Osteonics Corp. · Jul 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · DePuy Orthopaedics, Inc. · May 2000
RADIAL HEAD PROSTHESIS
K992220 · Smith & Nephew, Inc. · Feb 2000