1. Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.

Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis are indicated for patients with suspected cobalt allov sensitivity. The wear properties of Titanium and Titanium allovs are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Device Description

The Titanium Versa-Dial™ Humeral Head Prosthesis consists of a series of various-sized modular humeral heads with variable offset between 0.5mm and 4.5mm. The humeral heads consist of a shell head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System.

AI/ML Overview

The document does not describe the acceptance criteria for a medical device in terms of performance metrics like accuracy, sensitivity, or specificity, nor does it detail a study proving the device meets such criteria. This document is a 510(k) premarket notification summary for the "Titanium Versa-Dial™ Humeral Head Prosthesis."

Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing and engineering evaluations, rather than a clinical performance study with acceptance criteria.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The document does not present a table like this because it's not a study reporting performance against specific clinical acceptance criteria. The acceptance refers to engineering criteria for mechanical performance.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Torsional separation testing: Did not introduce new issues of safety or effectiveness.	"The testing showed that the titanium on titanium taper geometry met the acceptance criteria."
Axial disassembly of taper connection: Did not introduce new issues of safety or efficacy.	"The summary concluded that there were no new issues of safety and efficacy."
In vivo wear behavior: Wear of the subject device expected to be no worse than the predicate device.	"The results of the analysis indicate that the wear of the subject device would be expected to be no worse than the K915596 and K030710 predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Test set sample size: Not specified. The testing mentioned is non-clinical (torsional separation, axial disassembly, engineering analysis of wear), not involving patient data. The "test set" would refer to physical device samples or theoretical models for these non-clinical evaluations.
Data provenance: Not applicable in terms of patient data. The non-clinical testing would have been conducted by Biomet Manufacturing Corp. or their contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for engineering tests is based on established engineering principles and measurement techniques, not expert consensus on clinical findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept is relevant for clinical studies where multiple human readers interpret data, typically in diagnostic imaging or pathology. For non-clinical engineering tests, the results are objectively measured.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a medical device for orthopedic surgery (humeral head prosthesis), not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical implantable device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" is based on:
- Objective physical measurements: For torsional separation and axial disassembly strength.
- Engineering analysis and scientific principles: For wear behavior comparison, likely relying on material science, biomechanics, and simulation or established wear models.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The device design and materials are based on established engineering knowledge and previous predicate device designs.

9. How the ground truth for the training set was established:

Not applicable for the reasons mentioned above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three profiles forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2014

Biomet Manufacturing Corporation Mr. Brian Kincaid Global Project Manager - Regulatory SET 56 East Bell Drive Warsaw, Indiana 46582

Re: K140390

Trade/Device Name: Titanium Versa-Dial™ Humeral Head Prosthesis Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, HSD, KWS, KWT Dated: July 25, 2014 Received: July 31, 2014

Dear Mr. Kincaid:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

{1}------------------------------------------------

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K140390

Device Name: Titanium Versa-Dial™ Humeral Head Prosthesis Indications for Use:

1. Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

x Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Biomet Manufacturing Corp. logo. The logo is in black and white. The word "BIOMET" is in a stylized font, and the words "MANUFACTURING CORP." are in a simpler font below.

510(k) Summary

Preparation Date:	September 5, 2014
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587FDA Registration Number 1825034
Contact Person:	Brian KincaidGlobal Project ManagerPhone: (574) 372-3992Fax: (574) 372-1718Email: brian.kincaid@biomet.com
Proprietary Name:	Titanium Versa-Dial™ Humeral Head Prosthesis
Common Name:	Shoulder Prosthesis
Classification Code(s)/Name(s):	MBF - Prosthesis, Shoulder, Semi-Constrained, Metal/PolymerUncemented (888.3670)HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic,Uncemented (888.3690)KWS - Prosthesis, Shoulder, Semi-constrained CementedProsthesis (888.3660)KWT - Non-Constrained, Metal/Polymer Cemented (888.3650)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

The predicate devices are the Versa-Dial® Humeral Head Prosthesis, K060716 and the Bio-Modular Humeral Heads with IonGuard, K915596 and K030710.

Device Description:

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. Below the logo is the text "MANUFACTURING CORP." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.

Intended Use:

The Titanium Versa-Dial™ Humeral Head Prosthesis is intended for:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis. 2.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt allov sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Summary of Technologies:

The Titanium Versa-Dial™ Humeral Head Prosthesis uses the same technology as the previously cleared Versa-Dial™ Humeral Head Prosthesis, K060716. The subject device is manufactured from Ti-6Al-4V, instead of Co-Cr-Mo which is used in the predicate Versa-Dial Heads cleared in K060716.

Non-Clinical Testing:

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

{5}------------------------------------------------

Torsional separation testing was conducted to determine that the modified device did not introduce any new issues of safety or effectiveness. The testing showed that the titanium on titanium taper geometry met the acceptance criteria.

An engineering summary of previous testing related to axial disassembly of the Comprehensive Shoulder taper connection feature was provided to justify that the titanium on titanium mating material condition in the large portion of the taper (humeral head to taper adaptor) did not introduce new issues of safety and efficacy. The summary concluded that there were no new issues of safety and efficacy.

A comparative engineering analysis of design factors that influence in vivo wear behavior was conducted in order to demonstrate that the modified device did not introduce any new issues of safety or effectiveness. The results of the analysis indicate that the wear of the subject device would be expected to be no worse than the K915596 and K030710 predicate device.

Clinical Testing:

No clinical data submitted.

All trademarks are property of Biomet, Inc.

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

Regulation Number and Section

§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”