Cleared Traditional

K983592 - SULZER ORTHOPEDICS SYSORB INTERFERENCE ...

K983592 is an FDA 510(k) clearance for SULZER ORTHOPEDICS SYSORB INTERFERENCE ..., manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K983592 · Sulzer Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K983592

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K983592.
STAYFUSE
K990804 · Pioneer Surgical Technology · Apr 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · Biodynamic Technologies, Inc. · Mar 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
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829 · Tornier · Dec 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998