Cleared Special

K010310 - MODIFICATION TO TRIDENT ALL POLY CUP

K010310 is the FDA 510(k) clearance for MODIFICATION TO TRIDENT ALL POLY CUP by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Special 510(k) pathway after a 47-day FDA review.

K010310 · Howmedica Osteonics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2001
Decision
47d
Days
Class 2
Risk

K010310 is an FDA 510(k) clearance for the MODIFICATION TO TRIDENT ALL POLY CUP. 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 March 20, 2001 after a review of 47 days - a notably fast clearance cycle.

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

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K010310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2001
Decision Date March 20, 2001
Days to Decision 47 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
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 446
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K010310.
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · Exactech, Inc. · May 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529 · Medtronic Sofamor Danek USA, Inc. · Apr 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · Howmedica Osteonics Corp. · Apr 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666 · Corin USA · Feb 2001
TRIDENT ALL POLY CUP
K001956 · Howmedica Osteonics Corp. · Dec 2000
DEPUY C-STEM SYSTEM
K003421 · DePuy Orthopaedics, Inc. · Dec 2000