(31 days)
No
The document describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a medical implant intended to treat joint wear, fractures, and vascular necrosis, thus directly addressing and alleviating a medical condition.
No
This device is a femoral stem (part of a hip prosthesis), intended for surgical implantation to treat joint diseases, fractures, or post-operative conditions. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a "femoral component manufactured from forged stainless steel alloy," indicating it is a physical hardware device, 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, tissue) to provide information about a person's health.
- Device Description: The MS-30 Femoral Stem is a physical implantable device (a component of a hip replacement). It is surgically placed within the body.
- Intended Use: The intended use describes the conditions it is used to treat within the body, not the analysis of specimens outside the body.
Therefore, based on the provided information, the MS-30 Femoral Stem is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MS-30 Fernoral Stem is intended for cemented use in treatment of the following:
- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. .
- . Fractures or vascular necroses.
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, . hemiarthroplasty of total hip prosthesis (THP).
Product codes
LZO
Device Description
The MS-30 Stem is a highly polished, collarless femoral component manufactured from forged stainless steel alloy. It is available in six standard sizes and six lateral sizes. The lateral version offers the surgeon a 12% offsct versus the standard version. The MS-30 Stem is intended for cemented use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Performance tests, design comparisons, and functional analyses conducted on the MS-30 Femoral Stem demonstrate that it is substantially equivalent to the predicate devices.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
(fg lot)
510(k) SUMMARY APR 2 9 2004
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 432-9324
E-Mail: Robert.Wolfarth@Zimmer.com |
| TRADE NAME: | MS-30 Femoral Stem, Standard and Lateral |
| COMMON NAME: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis |
| CLASSIFICATION: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prostheses (Product Code 87 LZO) are Class
II per 21 CFR §888.3353, reviewed by the Orthopedic Devices pane |
PREDICATE DEVICES:
MS-30 Femoral Stem standard: K993043, K001078 MS-30 Femoral Stem lateral: K020713
DEVICE DESCRIPTION:
The MS-30 Stem is a highly polished, collarless femoral component manufactured from forged stainless steel alloy. It is available in six standard sizes and six lateral sizes. The lateral version offers the surgeon a 12% offsct versus the standard version. The MS-30 Stem is intended for cemented use.
INTENDED USE:
The MS-30 Fernoral Stem is intended for cemented use in treatment of the following:
- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. .
- . Fractures or vascular necroses.
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, . hemiarthroplasty of total hip prosthesis (THP).
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the MS-30 Femoral Stem demonstrate that it is substantially equivalent to the predicate devices.
1
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 three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
APR 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Zimmer. Inc. 9900 Spectrum Drive Austin, Texas 78717
Rc: K040803 Trade/Device Name: MS-30 Femoral Stem Standard and Lateral Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses Regulatory Class: II Product Code: LZO Dated: March 26, 2004 Received: March 30, 2004
Dear Mr. Wolfarth:
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 cquivalence 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Mr. Robert M. Wolfarth
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,
sincerely yours,
Mark A. 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
3
Indications for Use
510(k) Number (if known):
Device Name: MS-30 Femoral Stem Standard and Lateral
Indications For Use:
The MS-30 Femoral Stem is intended for cemented use in treatment of the following:
- Advanced wear of the joint due to degenerative, posttraumatic or rheumatic diseases. t
- Fractures or vascular necroses. .
- Status following earlier operations, such as joint reconstruction (osteotomy), arthrodesis, � hemiarthroplasty of total hip prosthesis (THP).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mikkelsen
Page 1 of Division of General, Restorative. and Neurological Devices
510(k) Number K040803