Cleared Special

K071784 - DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS

K071784 is an FDA 510(k) clearance for DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS, 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 23-day FDA review.

K071784 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jul 2007
Decision
23d
Days
Class 2
Risk

K071784 is an FDA 510(k) clearance for the DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS. 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 July 25, 2007 after a review of 23 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 - K071784

510(k) Number K071784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date July 25, 2007
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 K071784.
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963 · DePuy Orthopaedics, Inc. · Jan 2008
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
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REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc. · Oct 2007
VITALITY HIP SYSTEM MODEL#420
K070050 · Encore Medical, L.P. · May 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · Biomet, Inc. · Mar 2007
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822 · Stryker Orthopaedics · Jan 2007