(100 days)
No
The 510(k) summary describes a shoulder arthroplasty system with a focus on material coatings and component compatibility. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is a Bio-Modular® Shoulder System, intended for total or hemi shoulder arthroplasty, and is used to treat various conditions like osteoarthritis, rheumatoid arthritis, and fractures. These are therapeutic applications aimed at restoring function or alleviating symptoms.
No
The device is a shoulder arthroplasty system, consisting of components for total or hemi shoulder replacement. It is used for treatment and correction of conditions, not for diagnosis.
No
The device description clearly states it is a set of physical components (humeral stems, humeral heads, and glenoid components) for shoulder arthroplasty, which are hardware. The submission focuses on a change to the coating of these physical components.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "set of components intended for total or hemi shoulder arthroplasty." This means it's a surgical implant used to replace or repair a damaged shoulder joint.
- Intended Use/Indications for Use: The indications all relate to treating conditions affecting the shoulder joint through surgical intervention (arthroplasty).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indications For Use:
- Non-inflammatory degenerative joint 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).
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok") surface are indicated for cemented application only.
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.
Product codes
MBF
Device Description
The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.
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
Not Found
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
Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
Key Metrics
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
FEB 1 7 2005
BIOMET
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw, IN 46582
FDA Registration #: 1825034 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267 - 6639
FAX: (574) 372 - 1683 |
| Proprietary Name: | Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components |
| Common Name: | Shoulder prosthesis |
| Classification Name: | The Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components are included in the following classification:
- Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-constrained, Porous Coated, Uncemented Prosthesis 21 CFR § 888.3670 |
The Bio-Modular® Shoulder System has been cleared for:
- Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-constrained, Porous Coated, Uncemented Prosthesis 21 CFR § 888.3670
- Shoulder Joint, Metal/Polymer, Non-constrained, Cemented Prosthesis 21 CFR §888.3650
- Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented 21 CFR § 888.3660
- Shoulder Joint, Humeral, "Hemi-Shoulder," Metallic, Uncemented Prosthesis 21 CFR § 888.3690
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Bio-Modular® Shoulder System (K030710) – Biomet Inc.
Device Description: The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.
43
| MAILING ADDRESS
P.O. Box 587
Warsaw, IN 46581-0587 | SHIPPING ADDRESS
56 E. Bell Drive
Warsaw, IN 46582 |
| ---------------------------------------------------------- | ---------------------------------------------------------- |
|---|
574.267.6639
FAX
574.267.8137
.
E-MAIL biomet@biomet.com
트
1
p. 2/2
Intended Use:
Indications For Use:
-
- 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, ধ
- ડ. 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.
- A Humeral components with a Macrobond® surface coating are indicated for either cemented or uncemented press-fit applications.
- A 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).
- A Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok") surface are indicated for cemented application A only.
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application A only.
The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.
Summary of Technologies:
The Bio-Modular Shoulder System with the Hydroxyapatite coated glenoid components has the same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy as the predicate device.
- Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices.
- Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
All trademarks are property of Biomet. Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K043100
Trade Name: Bio-Modular® Shoulder System-Hydroxyapatite Coated Glenoid Components Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBF Dated: January 14, 2005 Received: January 18, 2005
Dear Mr. Baker:
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 svstems (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 - Mr. Gary Barker
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leket natification. The FDA finding of substantial equivalence of your device to a legally prematice hotified.om "Thesults 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 n you accire 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Indications For Use
510(k) Number (JF K NOWN) -
Device Name: Bio-Modular* Shoulder System – Hydroxyapatite Coated Glenoid Components
Indications For Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 1 .
-
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed, 3.
-
- Correction of functional deformity,
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate, 5.
- Difficult clinical management problems, including cuff arthropathy, where other methods of 6. treatment may not be suitable or may be inadequate.
- Humeral components with a Macrobond® surface coating are indicated for either cemented press-ﺮ ﺍ fit applications.
- Humeral glenoid components with a porous coated surface coating are indicated for either cemented or ﺮ uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for r uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok ) surface are indicated for cemented application only. ﻨﺮ
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. ﺮ
The Complehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components
Fhe Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System
Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use _ (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
and/or
Concurrence of CDRH. Office of Device Evaluation (ODE)
Mach N Mill
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices