(90 days)
Not Found
No
The summary describes a mechanical implant (elbow prosthesis) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a total elbow prosthesis, is intended to treat medical conditions such as Rheumatoid Arthritis, degenerative joint disease, and fractures, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an elbow prosthesis designed for implantation to treat various joint conditions, not for diagnosing them. Its purpose is to replace or assist the function of a damaged elbow joint.
No
The device description clearly details physical components made of materials like polyethylene, titanium, and cobalt chrome, indicating it is a hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or repairing the elbow joint due to various conditions like arthritis, fractures, and deformities. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical components of a prosthetic elbow joint (ulna and humeral components) made of materials like polyethylene, titanium, and cobalt chrome. These are materials used for implants, not for analyzing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
In summary, the ABC Elbow Prothesis is a medical device intended for surgical implantation, not for performing diagnostic tests on biological samples outside the body.
N/A
Intended Use / Indications for Use
The ABC (Anatomical Bone Conserving) Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory degenerative join disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods.
This device is a single use implant. It is intended for use with bone cement.
Product codes
JDB
Device Description
The ABC elbow is a total elbow prothesis. The implant consists of two components, an ulna and a humeral component.
The ulna is made up of two elements, the polyethylene articulating surface and the titanium stem. The polyethylene is compression molded onto the substrate. The articulating section is formed like part of a cylinder, the inner part being the polyethylene bearing and the outer being the substrate. The ulna component is designed to match the existing trochlea anatomy. This conserves bone and will improve the ease of implant alignment and fixation.
The substrate is roughened to enhance fixation to the cement interface. The stem is shaped to approximate to the internal geometry of the proximal ulna at the trochlea. The stem may be coated with a titanium plasma spray to provide additional cement fixation. The inner surface of the implant, the polyethylene bearing, is radiused in both axes.
The humeral component is a one piece cobalt chrome casting. The barrel is open ended and this matches the bone cut on the distal anterior humerus. The open section has been thickened internally to compensate for mechanical weakening caused by the removal of the closing section of the barrel. The transition from the barrel has been profiled to match the natural anatomy of the olecranon fossa. The support of the inside of the barrel and the gradual transition from barrel to stem ensure the mechanical strength of the barrel is not compromised. It requires less bone removal to implant the humeral component and the stem is designed to match the natural anatomy of the olecranon fossa and the surrounding borders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955099, K861680, K883665, K810847, K820957
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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OCT 1 5 1997
Image /page/0/Picture/2 description: The image shows the Biomet corporate headquarters logo. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. To the right of the word "BIOMET" is the word "INC" stacked vertically, with a registered trademark symbol above it. Below the logo are the words "CORPORATE HEADQUARTERS" in a smaller font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580
Device: ABC Total Elbow Prothesis
Classification Name: Elbow joint metal/polymer semi-constrained cemented prothesis. (888.3160)
Intended Use: The ABC (Anatomical Bone Conserving) Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory degenerative join disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods.
This device is a single use implant. It is intended for use with bone cement.
Device Description: The ABC elbow is a total elbow prothesis. The implant consists of two components, an ulna and a humeral component.
The ulna is made up of two elements, the polyethylene articulating surface and the titanium stem. The polyethylene is compression molded onto the substrate. The articulating section is formed like part of a cylinder, the inner part being the polyethylene bearing and the outer being the substrate. The ulna component is designed to match the existing trochlea anatomy. This conserves bone and will improve the ease of implant alignment and fixation.
The substrate is roughened to enhance fixation to the cement interface. The stem is shaped to approximate to the internal geometry of the proximal ulna at the trochlea. The stem may be coated with a titanium plasma spray to provide additional cement fixation. The inner surface of the implant, the polyethylene bearing, is radiused in both axes.
MAHING ADDRESS -- MALING ADDRESS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
SHIPPING ADDRESS
트
000097
FAX 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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The humeral component is a one piece cobalt chrome casting. The barrel is open ended and this matches the bone cut on the distal anterior humerus. The open section has been thickened internally to compensate for mechanical weakening caused by the removal of the closing section of the barrel. The transition from the barrel has been profiled to match the natural anatomy of the olecranon fossa. The support of the inside of the barrel and the gradual transition from barrel to stem ensure the mechanical strength of the barrel is not compromised. It requires less bone removal to implant the humeral component and the stem is designed to match the natural anatomy of the olecranon fossa and the surrounding borders.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delaved wound healing Fracture of the cement
Bone Fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Metal sensitivity Breakdown of porous surface
Substantial Equivalence: The ABC Total Elbow Prothesis is substantially equivalent to almost all elbow devices on the market in overall design and intended function. Predicate devices include:
Sorbie-Questor Total Elbow System (Wright Medical, 510(k) #K955099) Osteonics Elbow Prothesis (Osteonics, 510(k) #K861680) Coonrad III Total Elbow (Zimmer, 510(k) #K883665) Pritchard Elbow (Depuy, 510(k) #K810847) Surface Replacement Elbow (Howmedica, 510(k) # K820957) Capitello Condylar (Johnson & Johnson, Preamendment?)
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, and its body is formed by a series of lines that create a sense of movement. The overall design is simple and clean, with a focus on the department's name and the symbolic representation of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kara Mezger Glinical Research Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
OCT 1 5 1997
K972691 Re: Biomet IBC Elbow Prosthesis (Originally Submitted as ABC Total Elbow Prosthesis Regulatory Class: II Product Code: JDB Dated: July 16, 1997 Received: July 17, 1997
Dear Ms. Mezger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Kara Mezger
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely, yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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510(k) Number (if known): K972691
Device Name: ABC Total Elbow Prothesis
Indications For Use:
The ABC Elbow Prothesis is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods.
This device is a single use implant. It is intended for use with bone cement.
(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)
ﻤﻌﺎﻣﺔ
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division of General Restorative Devices 510(k) Number_K47269 |