(82 days)
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Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Modular Replacement Elbow System" intended for use in patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, due to tumor resection, trauma, failed prostheses, fractures, dislocations, and disabling joint diseases. This falls under the definition of a therapeutic device as it directly treats or alleviates a medical condition.
No
The device is described as a "Modular Replacement Elbow System" intended for surgical reconstruction of the distal humerus and elbow joint due to conditions like tumors, trauma, or arthritis. Its function is to replace or reconstruct the joint, not to diagnose a condition.
No
The device description clearly states it is a "Modular Replacement Elbow System" and describes "Humeral components" and "ulna components," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this is a surgical implant used for the reconstruction of bones (humerus and ulna) in the elbow and arm. It is a physical device implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
This device falls under the category of a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Modular Replacement Elbow System is intended for use in Oncology patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation.
The Modular Replacement Elbow System is also intended for use in patients requiring extensive reconstruction of the distal humerus necessitated by trauma, failed previous prosthesis, distal humeral fracture and/or dislocation, and disabling joint disease of the elbow resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Product codes
87 HSD, 87 JDC
Device Description
This submission is a line extension to the Howmedica Modular Replacement Systems for reconstruction of the humerus and ulna. Humeral components will be based on the design of the Howmedica Modular Proximal Humerus Replacement System and ulna components will be derived from the Osteonics® Total Elbow System.
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
distal humerus, elbow joint, humerus, ulna
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)
An engineering analysis was conducted to compare the strength of the subject modular replacement components to the predicate components. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howmedica Modular Proximal Humerus Replacement System, Osteonics® Total Elbow System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
KC62845
510(k) Summary of Safety and Effectiveness DEC I 3 2006 Modular Replacement Humeral and Ulna
| Proprietary Name: | Modular Replacement Elbow System |
|---|---|
| Common Name: | Modular Humeral and Ulna Components |
| Classification Name/Reference: | Shoulder joint humeral (hemi-shoulder) metallic |
| uncemented prosthesis, 21 CFR §888.3690 | |
| Elbow joint metal/polymer constrained cemented | |
| prosthesis, 21 CFR §888.3150 | |
| Device Product Code: | 87 HSD, 87 JDC |
| Proposed Regulatory Class: | |
| For Information contact: | Class II |
| Francisco Haro, Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5493 Fax: (201) 831-6038 | |
| Date Summary Prepared: | September 22, 2006 |
Description
This submission is a line extension to the Howmedica Modular Replacement Systems for reconstruction of the humerus and ulna. Humeral components will be based on the design of the Howmedica Modular Proximal Humerus Replacement System and ulna components will be derived from the Osteonics® Total Elbow System.
Indications:
The Modular Replacement Elbow System is intended for use in Oncology patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation. The Modular Replacement Elbow System is also intended for use in patients requiring extensive reconstruction of the distal humerus necessitated by trauma, failed previous prosthesis, distal humeral fracture and/or dislocation, and disabling joint disease of the elbow resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Substantial Equivalence:
The Modular Replacement Humeral and Ulna is substantially equivalent to the Howmedica Modular Proximal Humerus Replacement System and Osteonics® Total Elbow System in regards to intended use, design, materials, and operational principles as modular replacement components. An engineering analysis was conducted to compare the strength of the subject modular replacement components to the predicate components. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
DEC 1 3 2006
Re: K062845
Trade/Device Name: Modular Replacement Humeral and Ulna Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: HSD, JDC Dated: September 22, 2006 Received: September 22, 2006
Dear Mr. Haro:
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.
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Page 2 - Mr. Francisco Haro
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 vours,
Barbara Buchholz
Mark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Modular Replacement Humeral and Ulna
Indications for Use:
The Modular Replacement Elbow System is intended for use in Oncology patients requiring extensive reconstruction of the distal humerus, including the elbow joint and total humeral replacement, necessitated by extensive bone loss due to tumor resection. These prostheses are intended for use with bone cement as a means of intramedullary fixation.
The Modular Replacement Elbow System is also intended for use in patients requiring extensive reconstruction of the distal humerus necessitated by trauma, failed previous prosthesis, distal humeral fracture and/or dislocation, and disabling joint disease of the elbow resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Bonew
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062845