Cleared Traditional

K130126 - SIGNATURE PERSONALIZED PATIENT CARE SYS...

K130126 is the FDA 510(k) clearance for SIGNATURE PERSONALIZED PATIENT CARE SYS... by Biomet, Inc.. It is a Class 2 Orthopedic device (product code MBF) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K130126 · Biomet, Inc. · Orthopedic device
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Aug 2013
Decision
201d
Days
Class 2
Risk

K130126 is an FDA 510(k) clearance for the SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 6, 2013 after a review of 201 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K130126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2013
Decision Date August 06, 2013
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 33
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K130126.
Humeral Short Stem System
K173824 · Shoulder Innovations, Inc. · Oct 2018
SMR Hybrid Glenoid System
K163397 · Lima Corporate S.P.A. · Jun 2017
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
K140390 · Biomet Manufacturing Corp · Sep 2014
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K083439 · Synthes (Usa) · Feb 2009
ENCORE SHOULDER REVISION GLENOID
K081448 · Encore Medical, L.P. · Sep 2008
COFIELD TOTAL SHOULDER SYSTEM
K070565 · Smith & Nephew, Inc. · May 2007