Cleared Traditional

K131167 - UNIVATION

K131167 is an FDA 510(k) clearance for UNIVATION, manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K131167 · Aesculap Implant Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
176d
Days
Class 2
Risk

K131167 is an FDA 510(k) clearance for the UNIVATION. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 176 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 Aesculap Implant Systems, LLC devices

FDA 510(k) Submission Details - K131167

510(k) Number K131167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date October 17, 2013
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 77
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K131167.
SIGMA High Performance (HP) Partial Knee System
K193549 · Depuy Ireland UC · Apr 2020
NanoOrtho NanoKnee® System
K190633 · Nanoortho, LLC · Dec 2019
MPO Total Knee Systems MR Labeling
K152631 · Microport Orthopedics, Inc. · Mar 2016
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
K122277 · Biomet Manufacturing Corp · Oct 2012
SIGNATURE PLANNER / SIGNATURE GUIDES
K110415 · Materialise NV · May 2011
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973 · Wrightmedicaltechnologyinc · Aug 2010