Cleared Traditional

K983509 - INTER-OP ACETABULAR SYSTEM - DURASUL AC...

K983509 is an FDA 510(k) clearance for INTER-OP ACETABULAR SYSTEM - DURASUL AC..., manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

FDA 510(k) Submission Details - K983509

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
Combination Product No
PCCP Authorized No
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.

LPH Device Classification - Class 2, Special Controls

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 453
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