Cleared Traditional

K914878 - ZIRCONIUM ALLOY FRMORAL HEAD

K914878 is the FDA 510(k) clearance for ZIRCONIUM ALLOY FRMORAL HEAD by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K914878 · Smith & Nephew Richards, Inc. · Orthopedic device
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Jul 1992
Decision
274d
Days
Class 2
Risk

K914878 is an FDA 510(k) clearance for the ZIRCONIUM ALLOY FRMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 274 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K914878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date July 30, 1992
Days to Decision 274 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 122d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K914878.
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
K922421 · Kinamed, Inc. · Oct 1992
HOWMEDICA(R) HNR SYSTEM
K922503 · Howmedica Corp. · Sep 1992
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
K914675 · Kirschner Medical Corp. · Aug 1992
MODULAR ACETABULAR CUP SYSTEM
K920430 · Smith & Nephew Richards, Inc. · Jul 1992
RX 90 ACETABULAR COMPONENT SYSTEM
K920639 · Biomet, Inc. · Jun 1992
FULL HEMISPHERE RING-LOC LINER
K920640 · Biomet, Inc. · Jun 1992