Cleared Special

K120578 - ACCOLADE II HIP STEM

K120578 is an FDA 510(k) clearance for ACCOLADE II HIP STEM, manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code JDI cleared through the Special 510(k) pathway after a 31-day FDA review.

K120578 · Howmedica Osteonics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
31d
Days
Class 2
Risk

K120578 is an FDA 510(k) clearance for the ACCOLADE II HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Osteonics (Mahwah, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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.

FDA 510(k) Submission Details - K120578

510(k) Number K120578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2012
Decision Date March 29, 2012
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 541
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K120578.
METS MODULAR PROXIMAL FEMUR
K121056 · Stanmore Implants Worldwide , Ltd. · Sep 2012
METS MODULAR TOTAL FEMUR
K121055 · Stanmore Implants Worldwide , Ltd. · Sep 2012
SIGNATURE PLANNER,SIGNATURE GUIDES
K111863 · Materialise NV · Jun 2012
EXETER X3 RIMFIT ACETABULAR CUP
K111848 · Stryker Corp. · Oct 2011
EXETER HIP STEM
K110290 · Howmedica Osteonics Corp. · Sep 2011
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
K093646 · DePuy Orthopaedics, Inc. · Dec 2009
K120578 · ACCOLADE II HIP STEM
Download PDF FDA Summary Howmedica Osteonics