(284 days)
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No
The summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a humeral replacement system used to replace bone due to disease, trauma, or extensive bone loss, directly treating a medical condition.
No
The device is a humeral replacement system, which is a prosthetic device used for treatment (replacement of bone), not for diagnosis.
No
The device description explicitly states it is a "modular humeral replacement system consisting of head, body and stem segments" made from metal alloys, 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 medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that this device is a modular humeral replacement system designed to be implanted into the body to replace the proximal humerus.
- Intended Use: The intended use is to replace bone loss or bone disease in the proximal humerus. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the description and intended use, this device falls under the category of an implantable medical device or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"This device is indicated for use with bone cement."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma."
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
Proximal Humerus
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)
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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.
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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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§ 888.3690 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.
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510(k) Summary
510(k) Summary K954559
Device: Howmedica® Modular Proximal Humerus Replacement System
This device is a modular humeral replacement system consisting of head, body and stem segments. These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.
The head and stem segments are manufactured from cobalt-chromiummolybdenum (Vitallium®) alloy. The body segment is manufactured from titanium alloy.
The Modular Proximal Humerus Replacement System has design features which are equivalent to the features of various marketed products. These equivalent products include: the Proximal Humerus Replacement (Howmedica), Neer II Proximal Humerus (Howmedica), Neer III Modular Proximal Humerus (Kirschner), Select Shoulder (Intermedics), NJ Shoulder (DePuy), PMI Proximal Humeral Segmental System (Biomet), Precision Osteolock™ Femoral Stems (Howmedica), and P.C.A.® E-Series Hip (Howmedica).
For information contact: Margaret F. Crowe
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870