Cleared Traditional

K990849 - DURATION IV STERILIZATION PROCESS (ACET...

K990849 is the FDA 510(k) clearance for DURATION IV STERILIZATION PROCESS (ACET... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K990849 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 1999
Decision
280d
Days
Class 2
Risk

K990849 is an FDA 510(k) clearance for the DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 280 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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

Submission Details

510(k) Number K990849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date December 20, 1999
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 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 444
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K990849.
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · Exactech, Inc. · Jan 2000
REVELATION POROUS HIP STEM
K994070 · Encore Orthopedics, Inc. · Jan 2000
MODULAR REACH HIP
K994038 · Biomet, Inc. · Dec 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082 · Exactech, Inc. · Nov 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · Howmedica Osteonics Corp. · Nov 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · Zimmer, Inc. · Oct 1999