Cleared Traditional

DYNASTY ACETABULAR SYSTEM WITH CERAMIC (K130376) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130376 · Wrightmedicaltechnologyinc · Orthopedic device
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Jul 2013
Decision
139d
Days
Class 2
Risk

K130376 is an FDA 510(k) clearance for the DYNASTY ACETABULAR SYSTEM WITH CERAMIC. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 3, 2013 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K130376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2013
Decision Date July 03, 2013
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 286
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K130376.
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · Smith & Nephew, Inc. · Oct 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · Smith & Nephew, Inc. · Oct 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · Biomet, Inc. · Oct 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · Wrightmedicaltechnologyinc · May 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167 · Wrightmedicaltechnologyinc · Apr 2013
PROFEMUR TL CLASSIC HIP STEM
K123688 · Wrightmedicaltechnologyinc · Feb 2013