Non-Inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
indequate: 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 blological fixation applications. (Metal backed glenoid components offer optional screw fixation.)

Polyethylene glenold 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, and the glenold components of the Blo-Modular® Shoulder System.

The device is a single-use implant.

Device Description

The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a 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 Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for the Versa-Dial™ Humeral Head Prosthesis. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Here's a breakdown of why and what information is present:

Missing Information (and why):

1. A table of acceptance criteria and the reported device performance: Not present. 510(k) submissions typically do not involve pre-defined performance acceptance criteria for clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as a predicate device.
2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data from the manufacturer is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set data or expert-reviewed ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a medical device (prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable (no clinical training data presented).
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proving" the device (in the context of a 510(k)):

The proof provided in this 510(k) document is centered around demonstrating substantial equivalence to predicate devices. This is achieved by:

Device Description and Comparison to Predicates: The document details the Versa-Dial™ Humeral Head Prosthesis and explicitly states, "The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices." It also notes a redesign of the taper adaptor material (TT-6Al-4V vs. Co-Cr-Mo) and changed indicia, implying these changes do not alter substantial equivalence.
Non-Clinical Testing: The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This non-clinical testing (likely mechanical, material, and performance bench testing) is the primary "study" mentioned to support the device's functionality. No specific metrics or acceptance criteria for this non-clinical testing are provided in this summary, but the FDA's acceptance of the 510(k) implies these tests met regulatory expectations for substantial equivalence.
Clinical Testing: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is very common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through engineering analysis, material comparison, and non-clinical bench testing, and without the need for de novo clinical trials or pre-defined performance metrics against a clinical ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with black. The font is blocky and geometric, giving the word a strong and industrial appearance. The word is horizontally oriented and centered in the image.

JUN 1 2 2006

510(k) Summarv

Preparation Date:	June 8, 2006
Applicant/Sponsor:	Blomet Manufacturing Corp.
Contact Person:	Susan Alexander
Proprietary Name:	Versa-Dial™ Humeral Head Prosthesis
Common Name:	Shoulder Prosthesis

Classification Name:

Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR §888.3650) .
Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 5888.3660) .
Shoulder joint metal/polymer/metal/non-constrained or semi-constrained porous-coated . uncemented prosthesis (21 CFR 6888,3670)
. Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Versa-Dial™ Humeral Head Prosthesis; Blomet Manufacturing Corp. (K040610) .
. Blo-Modular® Shoulder System; Blomet Orthopedics, Inc. (K030710)
Absolute® Bl-Polar Shoulder System; Blomet Manufacturing Corp. (K002998) ●

Device Description: The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a 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 Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).

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

1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
Rheumatoid arthritis. 2)
Revision where other devices or treatments have falled. 3)
1. Correction of functional deformity.
1. Fractures of the proximal humerus where other methods of treatment are deemed Inadequate.
Difficuit dinical management problems, Including cuff tear arthropathy, where other ର) methods of treatment may not be sultable or may be Inadequate.

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

5-1
MAILING ADDRESS	SHIPPING ADDRESS
P.O. Box 587Warsaw, IN 46581 0587	56 E. Bell DriveWarsaw, IN 46582
OFFICE	FAX	E-MAIL
574.267.6639	574.267.8187	biomet@biomet.com

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Page 2 of 2 510(k) Summary; Versa-Dlal™ Humeral Head Prosthesis Blomet Manufacturing Corp.

Hymeral/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 Blo-Modular® Shoulder Stems, and the glenoid components of the Bio-Modular® Shoulder System.

The device is a single use implant.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices. The device has been redesigned since it was deared in K040610. The redesigned Versa-Dial™ taper adaptor is comprised of TT-6AI-4V; the predicate Versa-Dial™ taper adaptor is made of Co-Cr-Mo. The Indicla on the underside of the new device have changed from numbers to letters.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results Indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Unless otherwise noted, all trademarks are property of Blomet.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K060716 Trade/Device Name: 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, KWT, KWS, HSD Dated: March 16, 2006 Received: March 17, 2006

Dear Ms. Alexander:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Susan Alexander

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Semmler

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060716

Indications for Use

510(k) Number (if known):_

Device Name: Versa-Dial™ Humeral Head Prosthesis

Indications For Use:

The Versa-Dial™ Humeral Head Prosthesis Is intended for:

1. Non-Inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
indequate: 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 glenold components not attached to a metal back are indicated for cemented application only.

The device is a single-use implant.

X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

4-1

Hubert Lemmer

Division Sign-Of Division of General, Restorage of 1 and Neurological Devices

1060716 510(k) Number_

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.”