Cleared Traditional

K990135 - TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE

K990135 is an FDA 510(k) clearance for TRILOGY ACETABULAR SYSTEM LONGEVITY CRO..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K990135 · Zimmer, Inc. · Orthopedic device
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Jul 1999
Decision
180d
Days
Class 2
Risk

K990135 is an FDA 510(k) clearance for the TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 180 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K990135

510(k) Number K990135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date July 12, 1999
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K990135.
ZMR HIP SYSTEM-REVISION TAPER
K992667 · Zimmer, Inc. · Oct 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · Smith & Nephew, Inc. · Oct 1999
ENCORE FULLY COATED HIP
K992109 · Encore Orthopedics, Inc. · Aug 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · Smith & Nephew, Inc. · Jul 1999
TITANIUM LOW PROFILE SCREWS
K991807 · Biomet, Inc. · Jul 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · Implex Corp. · Jul 1999