Cleared Traditional

K130343 - CORIN TRINITY ACETABULAR SYSTEM WITH EX...

K130343 is an FDA 510(k) clearance for CORIN TRINITY ACETABULAR SYSTEM WITH EX..., manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K130343 · Corin USA · Orthopedic device
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May 2013
Decision
106d
Days
Class 2
Risk

K130343 is an FDA 510(k) clearance for the CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS. 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 May 28, 2013 after a review of 106 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

FDA 510(k) Submission Details - K130343

510(k) Number K130343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2013
Decision Date May 28, 2013
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

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 454
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K130343.
TRINITY ACETABULAR SYSTEM
K131647 · Corin USA · Sep 2013
AVENIR CEMENTED HIP STEM
K131884 · Zimmer GmbH · Aug 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · Wrightmedicaltechnologyinc · Jul 2013
INTRABLOCK BIOBALL HIP SYSTEM (IBS)
K123619 · Merete Medical GmbH · May 2013
CORIN METAFIX HIP STEM
K130634 · Corin USA · May 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · Wrightmedicaltechnologyinc · May 2013