Cleared Traditional

K022799 - TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE

K022799 is an FDA 510(k) clearance for TRIDENT SCREW HOLE PLUG AND TRIDENT BON..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022799 · Howmedica Osteonics Corp. · Orthopedic device
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Nov 2002
Decision
90d
Days
Class 2
Risk

K022799 is an FDA 510(k) clearance for the TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 21, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K022799

510(k) Number K022799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date November 21, 2002
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K022799.
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · Zimmer, Inc. · Apr 2003
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K030265 · Zimmer, Inc. · Mar 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · Smith & Nephew, Inc. · Feb 2003
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · DePuy Orthopaedics, Inc. · Nov 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · Exactech, Inc. · Nov 2002
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K023085 · Biomet Orthopedics, Inc. · Oct 2002