Cleared Traditional

K980925 - DURATION II TIBIAL INSERTS-ETHYLENE OXI...

K980925 is the FDA 510(k) clearance for DURATION II TIBIAL INSERTS-ETHYLENE OXI... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K980925 · Howmedica Corp. · Orthopedic device
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Dec 1998
Decision
280d
Days
Class 2
Risk

K980925 is an FDA 510(k) clearance for the DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), 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 888.3560 - 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 K980925 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 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 763
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K980925.
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K983733 · Sulzer Orthopedics, Inc. · Dec 1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
K980637 · Implex Corp. · Dec 1998
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K980632 · Howmedica Corp. · Dec 1998
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K983153 · Sulzer Orthopedics, Inc. · Dec 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · Sulzer Orthopedics, Inc. · Oct 1998