(87 days)
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No
The document describes a mechanical implant (humeral head prosthesis) with modular components and different surface coatings. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are non-clinical mechanical tests.
Yes
The device, a humeral head prosthesis, is intended to treat various joint diseases and deformities, which directly addresses medical conditions and aims to restore or improve physiological function.
No
This device is a prosthesis, specifically a humeral head prosthesis, intended for joint replacement and correction of deformities, not for diagnosing medical conditions.
No
The device description clearly states it is a "Humeral Head Prosthesis" consisting of physical components (modular humeral heads, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Versa-Dial™ Humeral Head Prosthesis is a physical implant designed to replace or augment the humeral head in the shoulder joint. It is a surgical device, not a diagnostic test performed on bodily fluids or tissues.
- Intended Use: The intended uses listed are all related to treating conditions affecting the shoulder joint through surgical implantation. None of the indications involve analyzing samples from the body for diagnostic purposes.
Therefore, the Versa-Dial™ Humeral Head Prosthesis falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Versa-Dial™ Humeral Head Prosthesis is intended for:
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- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
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- 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 tear 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MBF, KWT, KWS, HSD
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Shoulder (Humeral Head)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
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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:
-
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2)
- Revision where other devices or treatments have falled. 3)
-
- Correction of functional deformity.
-
- 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 587 | ||
| Warsaw, IN 46581 0587 | 56 E. Bell Drive | |
| Warsaw, IN 46582 | ||
| OFFICE | FAX | |
| 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.
3
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
4
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:
-
- 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.
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_