Cleared Abbreviated

K990369 - SYNERGY CEMENTED HIP STEM

K990369 is the FDA 510(k) clearance for SYNERGY CEMENTED HIP STEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Abbreviated 510(k) pathway after a 32-day FDA review.

K990369 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
32d
Days
Class 2
Risk

K990369 is an FDA 510(k) clearance for the SYNERGY CEMENTED HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K990369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date March 12, 1999
Days to Decision 32 days
Submission Type Abbreviated
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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Standards-based clearance path.

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 446
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K990369.
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · Biomet, Inc. · Jun 1999
8MM FORGED CEMENTED STEM
K991227 · Encore Orthopedics, Inc. · Jun 1999
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K990821 · Biopro, Inc. · Apr 1999
MODULAR PROTUSIO CUP
K990032 · Biomet, Inc. · Feb 1999
APF POROUS COATED LINE EXTENSION
K984154 · Biomet, Inc. · Feb 1999
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K980926 · Howmedica Corp. · Dec 1998