Cleared Traditional

K993259 - INTER-OP DURASUL ACETABULAR INSERTS/COC...

K993259 is an FDA 510(k) clearance for INTER-OP DURASUL ACETABULAR INSERTS/COC..., 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 163-day FDA review.

K993259 · Sulzer Orthopedics, Inc. · Orthopedic device
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Mar 2000
Decision
163d
Days
Class 2
Risk

K993259 is an FDA 510(k) clearance for the INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS. 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 March 10, 2000 after a review of 163 days - an extended review cycle.

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 - K993259

510(k) Number K993259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1999
Decision Date March 10, 2000
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
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 K993259.
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K000306 · DePuy Orthopaedics, Inc. · Mar 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · Biomet, Inc. · Mar 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · Zimmer, Inc. · Mar 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · Biomet, Inc. · Feb 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · Biomet, Inc. · Feb 2000