(64 days)
No
The document describes a mechanical shoulder implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for joint arthroplasty to treat various conditions like degenerative joint disease, rheumatoid arthritis, fractures, and functional deformity. These are all conditions that benefit from therapeutic intervention to alleviate symptoms and restore function.
No
The device is a Bi-Anqular® Shoulder System, intended for hemi- or total shoulder joint arthroplasty, and addresses various degenerative conditions, fractures, and deformities. Its purpose is to replace parts of the shoulder joint, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components made of titanium alloy and polyethylene, intended for surgical implantation. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The Bi-Anqular® Shoulder System is an implantable medical device designed to replace or repair the shoulder joint within the body. It is a physical component used in surgery.
- Intended Use: The intended use clearly describes surgical procedures (hemi- or total shoulder joint arthroplasty) to address various conditions affecting the shoulder joint. This is a therapeutic intervention, not a diagnostic test.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:
- 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
Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) and polyethylene components not attached to a metal backi are indicated for cemented application only.
Product codes
MBF
Device Description
The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.
The proximally tapered, collarless stem follows the natural contours of the humeral canal thus promoting evenly distributed stress off-loading. Cylindrical distal stems fill the humeral canal. Proximal fins contribute to rotational stability while suture holes in the fins allow for proximal reconstruction of complex humeral fractures. Durinq insertion, a K-wire can be placed into the version hole in the medial calcar region of the stem to allow exact version control of the component referencing off the patient's forearm.
Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.
The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.
The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.
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
Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous surface was provided.
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
NOV 2 0 2003
Image /page/0/Picture/2 description: The image shows the logo for Biomet Orthopedics Inc. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the phrase "ORTHOPEDICS INC." in a smaller, sans-serif font. The logo is simple and modern.
Summary of Safety and Effectiveness
Applicant/Sponsor:Biomet Orthopedics, Inc.
Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist
Proprietary Name: Bi-Angular® Shoulder System
Common or Usual Name: Total shoulder replacement components
Classification Name:
-
- Prosthesis, Shoulder, non-constrained, Cemented (21 CFR Section 888,3650)
-
- Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3660)
-
- Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented (21 CFR Section 888.3670)
-
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented (21 CFR Section 888.3690)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Bio-Modular® Shoulder System - K030710 Proximal Humeral Component - K925613
Device Description: The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.
The proximally tapered, collarless stem follows the natural contours of the humeral canal thus promoting evenly distributed stress off-loading. Cylindrical distal stems fill the humeral canal. Proximal fins contribute to rotational stability while suture holes in the fins allow for proximal reconstruction of complex humeral fractures. Durinq insertion, a K-wire can be placed into the version hole in the medial calcar region of the stem to allow exact version control of the component referencing off the patient's forearm.
Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.
page 1 of 2
SHIPPING ADDRE Airport Inclustrial Park Warsaw, IN 46580
E
OFFICE -
- 267 (1633)
MAILING ADDRESS
P.O. Box 587
Warsaw, IN 46581 0587
FAX
219.267.8137
1
The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.
The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.
Intended Use: The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:
-
- 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
Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) and polyethylene components not attached to a metal backi are indicated for cemented application only.
Summary of Technologies: The materials, surface finishes and processing of the Bi-Angular® Shoulder System are similar to the predicate device.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous surface was provided.
Clinical Testing: None provided
page 2 of 2
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, resembling a bird in flight.
NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K032895
Trade/Device Name: Bi-Angular® Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or seni-constrained porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBF Dated: September 16, 2003 Received: September 17, 2003
Dear Ms. Beres:
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 10 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 max publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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. Patricia Sandborn Beres
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
K037895 510(k) Number (if known):
Device Name: Bi-Anqular® Shoulder System
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
Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene components are indicated for cemented application only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devic
510(k) Number K032895
Over-The-Counter Use
(Optional Format 1-2-96)