(89 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI or ML technology. The intended uses are standard surgical procedures, and there is no mention of image processing, AI/ML terms, or performance studies that would typically be associated with AI/ML-enabled devices.
No
The device's intended uses, such as Total Shoulder Arthroplasty and Total Hip Arthroplasty, refer to surgical procedures rather than direct therapeutic actions performed by the device itself. The device appears to be an aid in surgical procedures rather than a device that provides therapy.
No
Explanation: The device's intended use, "Total Shoulder Arthroplasty," "Total Hip Arthroplasty," "Intramedullary Occlusion," and "Cement Pressurization," describes surgical procedures or components, not the diagnosis of a disease or condition. There is no mention of analysis, interpretation, or detection of medical conditions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Total Shoulder Arthroplasty, Total Hip Arthroplasty, Intramedullary Occlusion, Cement Pressurization) are all surgical procedures performed directly on a patient's body.
- Anatomical Site: The anatomical sites mentioned (Shoulder, Hip, Intramedullary) are parts of the human body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
The information provided describes a device used during surgical procedures on a patient, not a test performed on samples from a patient.
N/A
Intended Use / Indications for Use
Indications For Use:
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- Total Shoulder Arthroplasty
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- Total Hip Arthroplasty
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- Intramedullary Occlusion
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- Cement Pressurization
Product codes
87LZN, JDI, FTM
Device Description
Tornier Cement Restrictor Trade Name: Canal Plug, Cement Restrictor Common Name: Cement Obturator
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue or bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The implantation of a joint prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus and may be performed only by a qualified surgeon. Federal (United States) Law restricts this device to sale, distribution and use by or on the order of a physician only.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K9734/5=
ummary of Safety and tiveness Information Premarket Notification, Section 510(k)
ornier S.A.
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Device Name: 1.
Tornier Cement Restrictor Trade Name:
Canal Plug, Cement Restrictor Common Name:
Classification Name: Cement Obturator
- Establishment Name & Registration Number: 2.
Tornier S.A. Name:
8020756 Number:
- Classification: 3.
Cement Obturator, 21 CFR, §878.3300
& 878.3300 Surgical mesh. (a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of interiod mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II.
Device Class: Class II
Classification Panel: Orthopaedic
Product Code: 87LZN
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Special Controls: 4.
Not applicable to this device. -
- Labeling:
IMPORTANT: The implantation of a joint prosthesis requires a knowledge of anatomy, biomechanics and reconstructive surgery of the locomotive apparatus and may be performed only by a qualified surgeon. The surgeon must operate in accordance with current information on the state of scientific progress and the art of surgery.
- Labeling:
Federal (United States) Law restricts this device to sale, distribution and use by or on the order of a physician only.
Warnings and cautions: Never re-use an implant, even if it is in perfect condition. Never resterilize an implant.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1997
Mr. David W. Schlerf ·Buckman Company, Inc. Representing Tornier S.A. 1000 Burnett Avenue, Suite 450 94520 Concord, California
K973453 Re : Tornier Cement Restrictor Requlatory Class: II Product Codes: JDI and FTM Dated: August 20, 1997 Received: September 11, 1997
Dear Mr. Schlerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. David W. Schlerf
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
facolleto
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
K973453
Device Name: Tornier Cement Restrictor
Indications For Use:
)
3
)
)
J
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- Total Shoulder Arthroplasty
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- Total Hip Arthroplasty
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- Intramedullary Occlusion
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- Cement Pressurization
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Ked Prairie Devices 73453 510(k) Number Prescription Use × OR Over-The-Counter Use __ (Per 21 CFR 801.109)
(Optional format 1-2-96)
Cement.doc