Cleared Traditional

K972893 - PARTNERSHIP REVISION FEMORAL STEMS

K972893 is the FDA 510(k) clearance for PARTNERSHIP REVISION FEMORAL STEMS by Howmedica Corp.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972893 · Howmedica Corp. · Orthopedic device
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Nov 1997
Decision
90d
Days
Class 2
Risk

K972893 is an FDA 510(k) clearance for the PARTNERSHIP REVISION 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 Corp. (Rutherford, US). The FDA issued a Cleared decision on November 3, 1997 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 Howmedica Corp. devices

Submission Details

510(k) Number K972893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1997
Decision Date November 03, 1997
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 420
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K972893.
MERIDIAN TITANIUM FEMORAL STEMS
K972228 · Howmedica, Inc. · Dec 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
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · Zimmer, Inc. · Oct 1997
PRECEDENT REVISION HIP SYSTEM
K972637 · Sulzer Orthopedics, Inc. · Oct 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · Howmedica, Inc. · Sep 1997