Cleared Traditional

K980926 - DURATION II ACETABULAR COMPONENTS-ETHYL...

K980926 is the FDA 510(k) clearance for DURATION II ACETABULAR COMPONENTS-ETHYL... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K980926 · Howmedica Corp. · Orthopedic device
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Dec 1998
Decision
280d
Days
Class 2
Risk

K980926 is an FDA 510(k) clearance for the DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 280 days - an extended review cycle.

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 Corp. devices

Submission Details

510(k) Number K980926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1998
Decision Date December 16, 1998
Days to Decision 280 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
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 433
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K980926.
SYNERGY CEMENTED HIP STEM
K990369 · Smith & Nephew, Inc. · Mar 1999
MODULAR PROTUSIO CUP
K990032 · Biomet, Inc. · Feb 1999
APF POROUS COATED LINE EXTENSION
K984154 · Biomet, Inc. · Feb 1999
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K980626 · Howmedica Corp. · Dec 1998
OSTEONICS X CEMENTED HIP STEM SERIES
K983226 · Osteonics Corp. · Dec 1998
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
K983128 · Implex Corp. · Dec 1998