Cleared Traditional

K972228 - MERIDIAN TITANIUM FEMORAL STEMS

K972228 is an FDA 510(k) clearance for MERIDIAN TITANIUM FEMORAL STEMS, manufactured by Howmedica, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K972228 · Howmedica, Inc. · Orthopedic device
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Dec 1997
Decision
175d
Days
Class 2
Risk

K972228 is an FDA 510(k) clearance for the MERIDIAN TITANIUM FEMORAL STEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on December 5, 1997 after a review of 175 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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, Inc. devices

FDA 510(k) Submission Details - K972228

510(k) Number K972228 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 13, 1997
Decision Date December 05, 1997
Days to Decision 175 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 122d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 512
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K972228.
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K980081 · Johnson & Johnson Professionals, Inc. · Apr 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837 · Sulzer Orthopedics, Inc. · Jan 1998
NATURAL-HIP COCR OFFSET STEM
K973681 · Sulzer Orthopedics, Inc. · Dec 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261 · Whiteside Biomechanics, Inc. · Nov 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · Johnson & Johnson Professionals, Inc. · Nov 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · Sulzer Orthopedics, Inc. · Nov 1997