(16 days)
Not Found
No
The summary describes a mechanical implant (humeral stem) and its intended use in surgical reconstruction. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The change from the predicate device is the absence of a porous coating.
Yes
The device is intended for the reconstruction of the proximal humerus due to extensive bone loss, which is a therapeutic intervention.
No
This device is described as a "humeral stem" intended for "reconstruction of the proximal humerus due to extensive bone loss" and for use "with bone cement." Its function is clearly for surgical replacement and reconstruction, not for diagnosis.
No
The device description clearly states it is a humeral stem, which is a physical 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 reconstructing the proximal humerus due to bone loss from tumor resection. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is a humeral stem, a physical implant. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any other activity associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or prosthetic, not an IVD.
N/A
Intended Use / Indications for Use
The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559.
Product codes
87 HSD
Device Description
The predicate MRS Humeral Stems had a porous coated body (or seat) segment. The subject MRS Humeral Stems do not have a porous coated body segment. The subject stems are offered in the same diameters, and the same lengths as the previously released porous coated humeral stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
| Line Extension to the Modular Replacement System Humeral Stems | Special 510(k) Premarket Notification | ||
|---|---|---|---|
| AUG - 8 2003 | |||
| Special 510(k) Summary | |||
| Proprietary Name: | Modular Replacement System (MRS) Humeral | ||
| Stems | |||
| Common Name: | Modular Humeral Stems | ||
| Classification Name and Reference: | Prosthesis, shoulder, hemi-, humeral, metallic | ||
| uncemented | |||
| 21 CFR §888.3690 | |||
| Proposed Regulatory Class: | Class II | ||
| Device Product Code: | 87 HSD | ||
| Predicate Proprietary Name: | MRS Humeral Stems | ||
| Predicate Regulatory Class: | Class II | ||
| Predicate Product Code: | 87 HSD | ||
| For Information contact: | Margaret F. Crowe | ||
| Howmedica Osteonics Corp. | |||
| 59 Route 17 | |||
| Allendale, New Jersey 07401-1677 | |||
| Phone: (201) 831-5580 | |||
| Fax: (201) 831-6038 |
Description/Technological Comparison
The predicate MRS Humeral Stems had a porous coated body (or seat) segment. The subject MRS Humeral Stems do not have a porous coated body segment. The subject stems are offered in the same diameters, and the same lengths as the previously released porous coated humeral stems.
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Intended Use
The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559.
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers. The symbol is composed of thick, curved lines, giving it a modern and minimalist appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Re: K032264
Trade/Device Name: Modular Replacement System (MRS) Humeral Stem Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: July 22, 2003 Received: July 23, 2003
Dear Ms. Crowe:
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 - Ms. Margaret F. Crowe
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
Special 510(k) Premarket Notification-Line Extension to MRS Humeral Stems
510(k) Number (if known): K
Line Extension to MRS Humeral Stems -- MRS Humeral Stems without Device: Porous Coated Body
The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-the Counter-Use 801.109)
Miriam C. Provost
torative
510(k) Number K032264