Cleared Traditional

SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS (K983592) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983592 · Sulzer Orthopedics, Inc. · Orthopedic device
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Jan 1999
Decision
107d
Days
Class 2
Risk

K983592 is an FDA 510(k) clearance for the SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Sulzer Orthopedics, Inc. devices

Submission Details

510(k) Number K983592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 28, 1999
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K983592.
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · Smith & Nephew, Inc. · Jan 1999
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · Osteonics Corp. · Dec 1998