(65 days)
No
The summary describes a traditional orthopedic implant (humeral stem) and its material properties, with no mention of AI or ML.
Yes
The device is described as "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," which directly indicates it is used for treatment.
No
This device is a humeral stem intended for reconstructive surgery of the proximal humerus, not for diagnosing conditions.
No
The device description clearly states it is a humeral stem fabricated from cobalt-chromium alloy, which is a physical implant, not software.
Based on the provided text, 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 device used in vivo (within the body).
- Device Description: The device is described as a humeral stem fabricated from cobalt-chromium alloy, which is a material used for surgical implants.
- 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.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
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 and K032264.
Product codes
87 HSD
Device Description
Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobaltchromium alloy that conforms to ASTM F-1537. It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has slightly different metallurgical properties.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
MAR 2 6 2004
Modular Replacement System Humeral Stems - Alternate Material
Special 510(k) Premarket Notification
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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. | |
| DBA Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| Phone: (201) 831-5580 | |
| Fax: (201) 831-6038 |
Description/Technological Comparison
Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobaltchromium alloy that conforms to ASTM F-1537. It is the intention of Howmedica Osteonics Corp. to fabricate the non-porous coated humeral stems in the MRS system from a slightly different type of cobalt-chromium - this material also conforms to ASTM F-1537, but has
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040148
page 2 of 2
Special 510(k) Prem
slightly different metallurgical properties.
Intended Use
The intended usc of the subject device is not changed by this material change: 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 humcrus 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 and K032264.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K040128
Trade/Device Name: Modular Replacement System Humeral Stems - Alternate Material Regulation Number: 21 CFR 888.3690 Regulatory Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: March 4, 2004 Received: March 8, 2004
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
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Page 2 - Margaret F. Crowe
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. 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.
b. Mark N. Millman
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- Modular Replacement System Humeral Stems -Alternate Material
510(k) Number (if known): K. NUI l 27
Device: Modular Replacement System Humeral Stems - Alternate Material
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 and K032264.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (/ OR Over-the Counter-Use (per 21 CFR 801.109)
Mark N. Millman
al. Restorative, Division of Gene and Neurological Devices
510(k) Number K040128