(208 days)
No
The 510(k) summary describes a mechanical implant (humeral head prosthesis) and its intended use and testing. There is no mention of software, algorithms, image processing, AI, ML, or any data sets for training or testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is a prosthesis indicated for conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, and fractures of the proximal humerus, which are all treated as part of therapeutic medical interventions.
No
This device is a humeral head prosthesis, which is an implant used in shoulder replacement surgery to treat conditions like arthritis and fractures. It is a treatment device, not a diagnostic one. Its stated 'Intended Use' describes conditions it is used to address, not to identify or diagnose.
No
The device description clearly states it is a "Humeral Head Prosthesis" consisting of physical components (shell head, taper adaptor) intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description and Intended Use: The description clearly states that this is a "Humeral Head Prosthesis" and its intended use is for surgical implantation in the shoulder joint to treat various conditions like osteoarthritis, rheumatoid arthritis, fractures, etc. This is an implantable medical device used inside the body.
The information provided focuses on the physical characteristics of the implant, its materials, how it connects to other components, and its intended surgical applications. There is no mention of testing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- 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.
Product codes
MBF, HSD, KWS, KWT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical data submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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:
-
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- 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.
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
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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 Drive | |
| P.O. Box 587 | |
| Warsaw, Indiana 46581-0587 | |
| FDA Registration Number 1825034 | |
| Contact Person: | Brian Kincaid |
| Global Project Manager | |
| Phone: (574) 372-3992 | |
| Fax: (574) 372-1718 | |
| Email: 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/Polymer |
| Uncemented (888.3670) | |
| HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic, | |
| Uncemented (888.3690) | |
| KWS - Prosthesis, Shoulder, Semi-constrained Cemented | |
| Prosthesis (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:
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.
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:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
-
- Revision where other devices or treatments have failed.
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
- 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 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