Cleared Special

K000306 - PINNACLE ACETABULAR SYSTEM

K000306 is an FDA 510(k) clearance for PINNACLE ACETABULAR SYSTEM, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 51-day FDA review.

K000306 · DePuy Orthopaedics, Inc. · Orthopedic device
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Mar 2000
Decision
51d
Days
Class 2
Risk

K000306 is an FDA 510(k) clearance for the PINNACLE ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K000306

510(k) Number K000306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date March 23, 2000
Days to Decision 51 days
Submission Type Special
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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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 K000306.
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830 · Biomet, Inc. · Apr 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321 · Ortho Development Corp. · Apr 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154 · Plus Orthopedics · Apr 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · Biomet, Inc. · Mar 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · Sulzer Orthopedics, Inc. · Mar 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · Zimmer, Inc. · Mar 2000