Cleared Traditional

K992667 - ZMR HIP SYSTEM-REVISION TAPER

K992667 is the FDA 510(k) clearance for ZMR HIP SYSTEM-REVISION TAPER by Zimmer, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K992667 · Zimmer, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
79d
Days
Class 2
Risk

K992667 is an FDA 510(k) clearance for the ZMR HIP SYSTEM-REVISION TAPER. 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 October 27, 1999 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K992667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date October 27, 1999
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K992667.
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
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K993082 · Exactech, Inc. · Nov 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · Howmedica Osteonics Corp. · Nov 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · Smith & Nephew, Inc. · Oct 1999
ENCORE FULLY COATED HIP
K992109 · Encore Orthopedics, Inc. · Aug 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135 · Zimmer, Inc. · Jul 1999