Cleared Special

DYNASTY ACETABULAR SHELL (K061547) - FDA 510(k) Clearance

Also marketed or referenced as:
DYNASTY A-CLASS POLY ACETABULAR LINER

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061547 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
28d
Days
Class 2
Risk

K061547 is an FDA 510(k) clearance for the DYNASTY ACETABULAR SHELL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 28 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K061547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date July 03, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K061547.
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786 · Zimmer, Inc. · Jul 2006
PCA 36MM FEMORAL HEADS
K061168 · Howmedica Osteonics Corp. · Jul 2006
DEPUY AML HIP PROSTHESIS
K061833 · DePuy Orthopaedics, Inc. · Jul 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · Smith & Nephew, Inc. · Jun 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · DePuy Orthopaedics, Inc. · May 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · Zimmer, Inc. · May 2006