Cleared Special

K013676 - TRIDENT HEMISPHERICAL ACETABULAR SHELLS

K013676 is the FDA 510(k) clearance for TRIDENT HEMISPHERICAL ACETABULAR SHELLS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Special 510(k) pathway after a 28-day FDA review.

K013676 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2001
Decision
28d
Days
Class 2
Risk

K013676 is an FDA 510(k) clearance for the TRIDENT HEMISPHERICAL ACETABULAR SHELLS. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K013676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date December 05, 2001
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 130
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K013676.
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · Howmedica Osteonics Corp. · May 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · Biomet Orthopedics, Inc. · Apr 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · Howmedica Osteonics Corp. · Mar 2002
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · Smith & Nephew, Inc. · Dec 2000
GROSS FEMORAL COMPONENT
K001580 · Biomet, Inc. · Aug 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · Howmedica Osteonics Corp. · Aug 2000