Cleared Traditional

K980081 - S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD

K980081 is the FDA 510(k) clearance for S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980081 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Apr 1998
Decision
90d
Days
Class 2
Risk

K980081 is an FDA 510(k) clearance for the S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on April 9, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K980081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1998
Decision Date April 09, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 435
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K980081.
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774 · Osteonics Corp. · Apr 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
K980239 · Howmedica, Inc. · Apr 1998
PRESS-FIT STEM
K980473 · Encore Orthopedics, 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
MERIDIAN TITANIUM FEMORAL STEMS
K972228 · Howmedica, Inc. · Dec 1997