Cleared Traditional

K990849 - DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)

K990849 is an FDA 510(k) clearance for DURATION IV STERILIZATION PROCESS (ACET..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K990849

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.

LPH Device Classification - Class 2, Special Controls

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 539
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