Cleared Traditional

INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT (K983509) - FDA 510(k) Clearance

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

K983509 · Sulzer Orthopedics, Inc. · Orthopedic device
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Feb 1999
Decision
119d
Days
Class 2
Risk

K983509 is an FDA 510(k) clearance for the INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 3, 1999 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K983509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1998
Decision Date February 03, 1999
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K983509.
ECHELON HIP STEM
K983834 · Smith & Nephew, Inc. · Feb 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296 · Biomet, Inc. · Feb 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · Biomet, Inc. · Feb 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459 · DePuy Orthopaedics, Inc. · Jan 1999
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
K983502 · Osteonics Corp. · Dec 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491 · DePuy Orthopaedics, Inc. · Dec 1998