Cleared Traditional

TRINITY ACETABULAR SYSTEM (K131647) - FDA 510(k) Clearance

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

K131647 · Corin USA · Orthopedic device
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Sep 2013
Decision
114d
Days
Class 2
Risk

K131647 is an FDA 510(k) clearance for the TRINITY ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 114 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 Corin USA devices

Submission Details

510(k) Number K131647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2013
Decision Date September 27, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 309
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K131647.
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
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · Wrightmedicaltechnologyinc · Jul 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · Wrightmedicaltechnologyinc · May 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167 · Wrightmedicaltechnologyinc · Apr 2013