(29 days)
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No
The summary describes a mechanical implant (humeral stem) and its intended use in shoulder replacement surgery. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies focus on mechanical strength, not algorithmic performance.
Yes
The device is intended for shoulder replacement to treat painful, disabling joint diseases, fractures, and aseptic necrosis, indicating its use to alleviate or cure a disease or condition.
No
The device is a humeral stem intended for shoulder replacement, which is a therapeutic and reconstructive procedure, not a diagnostic one. Its purpose is to treat conditions, not to identify or diagnose them.
No
The device description clearly states it is a "humeral stem," which is a physical implant used in shoulder replacement surgery. This is a hardware device, not software.
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, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states this is a "humeral stem" intended for "shoulder replacement" and "reconstruction of the proximal humerus." This is a surgical implant, designed to be placed inside the body.
- Intended Use: The intended use describes the conditions for which the device is used in a surgical procedure (e.g., aseptic necrosis, arthritis, fractures). It does not involve testing bodily specimens.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.
Indications for Use:
For use as a Bipolar Shoulder Replacement:
- . Aseptic necrosis of the humeral head
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- . Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- . Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- . Aseptic necrosis of the humeral head
- . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Product codes (comma separated list FDA assigned to the subject device)
87 KWS, 87 HSD
Device Description
This submission is a line extension to the Solar® ReUnion™ Fracture Stem for fracture humeral stem with no CP Ti plasma spray. Fracture humeral stems will be based on the Solar® ReUnion™ Fracture Stem.
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
Shoulder joint, 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.
0
- 4 2007
MAY - 4 2007
Summary of Safety and Effectiveness ReUnion™ HA Fracture Stem
| Proprietary Name: | ReUnion™ HA Fracture Stem |
|---|---|
| Common Name: | Shoulder Prosthesis |
| Classification Name and Reference: | Shoulder joint metal/polymer semi |
| constrained cemented prosthesis. 21 CFR | |
| §888.3660 | |
| Shoulder joint humeral (hemi-shoulder) | |
| metallic uncemented prosthesis. 21 CFR | |
| §888.3690 | |
| Device Product Code: | 87 KWS, 87 HSD |
| For Information Contact: | 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: | April 3, 2007 |
Description:
This submission is a line extension to the Solar® ReUnion™ Fracture Stem for fracture humeral stem with no CP Ti plasma spray. Fracture humeral stems will be based on the Solar® ReUnion™ Fracture Stem.
Intended Use:
The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.
Indications for Use:
For use as a Bipolar Shoulder Replacement:
- . Aseptic necrosis of the humeral head
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- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- . Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- . Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- . Aseptic necrosis of the humeral head
- . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Substantial Equivalence:
The ReUnion™ HA Fracture Stem is substantially equivalent to the Solar® ReUnion™ Fracture Stem in regards to intended use, design, materials, and operational principles as humeral components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2007
Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K070963
Trade/Device Name: ReUnion™ HA Fracture Stem Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: April 3, 2007 Received: April 5, 2007
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/dsma/dsmamain.html
Sincerely yours,
Валеше Вuekup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: ReUnion™ HA Fracture Stem
Indications for Use:
For use as a Bipolar Shoulder Replacement:
- . Aseptic necrosis of the humeral head
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative . glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- . Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Off Division of General, Restorative. and Neurological Devices
510(k) Number K070963
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