Cleared Traditional

K130126 - SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM

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

K130126 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K130126

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.

MBF Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K130126.
SMR Hybrid Glenoid System
K163397 · Lima Corporate S.P.A. · Jun 2017
ARROW Anatomical Porous glenoid
K162068 · Fournitures Hospitalieres Industrie · Apr 2017
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
K140390 · Biomet Manufacturing Corp · Sep 2014
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K123297 · Biomet Manufactuting Corp. · Nov 2012
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K112905 · Biomet Orthopedics, LLC · May 2012
SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM
K083439 · Synthes (Usa) · Feb 2009