(49 days)
No
The summary describes a physical implant (liner) for hip revision surgery and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is a component of a hip replacement system, indicated for use as a bearing surface in a Trabecular Metal Revision Shell. This is a direct intervention to treat joint instability, wear, and damage, which are conditions affecting the physical health and function of a patient.
No
The device is a polyethylene bearing surface for joint replacement, not a tool for diagnosing medical conditions. Its intended use is for cemented use in a revision shell for hip joint instability, wear, and/or damage.
No
The device description clearly states it is a "Trabecular Metal Revision Shell Liner," which is a physical implant component for hip replacement surgery. It is 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. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Trabecular Metal Revision Shell Liner is a physical implant designed to be placed within the hip joint. Its purpose is to provide a bearing surface for joint stability and address wear or damage. It is used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes based on laboratory results.
Therefore, based on the provided information, the Trabecular Metal Revision Shell Liner is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trabecular Metal Revision Shell Liners are indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
Product codes
JDI
Device Description
This modified device is intended for cemented use in conjunction with a Trabecular Metal Revision Shell. The liner is offered in a broad range of sizes with 0- and 10-degree face angle versions to accommodate a variety of patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device.
Clinical data and conclusions were not needed for this device.
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
§ 888.3350 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
Image /page/0/Picture/0 description: The image contains the word "zimmer" in bold, black font. To the left of the word is a circle with a bold, black "Z" inside. There is a horizontal line underneath the word "zimmer". The logo appears to be for the Zimmer company.
ﺪ ﺍ
Summary of Safety and Effectiveness
JUL 2 7 2005
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain
Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4219
Fax: (574) 372-4605 |
| Date: | June 7, 2005 |
| Trade Name: | Trabecular Metal™ Revision Shell Liners |
| Common Name: | Acetabular Cup |
| Classification Name
and Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,
Cemented
21 CFR § 888.3350 |
| Predicate Device: | Implex Hedrocel® Replacement Cup Insert,
manufactured by Zimmer TMT (formerly known as
Implex), K983128, cleared December 3, 1998. |
| Device Description: | This modified device is intended for cemented use
in conjunction with a Trabecular Metal Revision
Shell. The liner is offered in a broad range of sizes
with 0- and 10-degree face angle versions to
accommodate a variety of patient anatomies. |
| Intended Use: | The Trabecular Metal Revision Shell Liners are
indicated for cemented use in the Trabecular Metal
Revision Shell for initial placement or as an in situ
replacement polyethylene bearing surface for joint
instability, wear and/or damage. |
| Comparison to Predicate Device: | Except for a change in material and minor
dimensional changes, the Trabecular Metal
Revision Shell Liners are identical to the predicate
device. The modified device uses the same
operating principle, intended uses and fixation
method as the predicate device. |
:
1
Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter Z inside of a circle, followed by the word "zimmer" in lowercase letters. The logo is black and white.
K051516/S1
Special 510(k): Device Modification
1 20
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Ms. Karen Cain Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K051516
Trade/Device Name: Trabecular Metal™ Revision Shell Liners Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: July 14, 2005 Received: July 15, 2005
Dear Ms. Cain:
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.
3
Page 2 - Ms. Karen Cain
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wifi anow you to organizal equivalence of your device of your device to a legally premarket notification: "The Pro Printings of 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 If you doon't 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 other general mionnal 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,
St. Kipti Church
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 051576/51
Indications for Use
510(k) Number (if known):
Device Name:
Trabecular Metal™ Revision Shell Liners
Indications for Use:
The Trabecular Metal Revision Shell Liner is indicated for cemented use in the Trabecular Metal THE Travet and Mellar Revision Bhich Ement polyethylene bearing surface for joint instability, wear and/or damage.
Prescription Use _X (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)
Hyt Slurdu
(Division 'Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
KOS 1516 510(k) Number.