(159 days)
No
The document describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a component of a total hip prosthesis, which is used to replace a diseased or damaged hip joint and restore its function, thus treating a medical condition.
No
The device, Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner, is an implantable component of a total hip prosthesis, used for treating conditions that cause hip dislocation. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of polyethylene and titanium alloy, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant used in hip replacement surgery. It is a physical component (acetabular liner) that is placed inside the patient's body.
- Intended Use: The intended use clearly states it is a "component of a total hip prosthesis" and is "intended to be cemented into a TMARS shell is intended for cementless fixation into the acetabulum." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell, the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
Product codes (comma separated list FDA assigned to the subject device)
87 KWZ
Device Description
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring.
The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs.
Subject acetabular liners are available in mner diameters of 28. 32 and 36mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint / Acetabulum
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)
Mechanical Testing of the modified device indicates that it is substantially equivalent to the predicate. Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
K072121
Summary of Safety and Effectiveness
Submitter:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names and References:
Predicate Device:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
JAN - 7 2008
Patricia Jenks Specialist, Corporate Regulatory Affairs Telephone: (574) 371-8354 Fax: (574) 372-4605
October 11. 2007
Trabecular MetaltM Acetabular Revision System Cemented Constrained Liner
Constramed Acctabular Liner
21 CFR 888,3310: Hip joint metal | polymer constrained cemented or uncemented prosithesis, Product code: 87 KWZ
Trilogy" Longevity * Constrained Liner, K071718, cleared July 13, 2007 and Trabecular Metal Revision Shell Liners, K051516, cleared July 27, 2005
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring.
The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs.
:
and the comments of the country of the
1
diameters of 28. 32 and 36mm. The Trabecular Metal Acetabular Revision System Intended Use: (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell, the shell is intended for comentless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acctabular components have been considered. Comparison to Predicate Device: Two predicates form the design of the Trahecular Metal Acetabular Revision System Cemented Constrained Liner. The from side/femoral head capture region exactly matches the Trilogy Longevity Constrained Liner and the backside has been modified with cement interdigitation grooves to allow for cement fixation into a Trabecular Metal Acetabular Revision Shell, exactly matching the backside of the Trabecular Metal Revision Shell Liners. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or (Clinical): Mechanical Testing of the modified device indicates that it is substantially equivalent to the predicate. Clinical Performance and Conclusions: Clinical data and conclusions were not needed
for this device.
the submit the submit and the submit of the subject of
Subject acetabular liners are available in mner
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping, curved lines that resemble a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.
Public Health Service
JAN - 7 2008
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Zimmer. Inc. c/o Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, IN 46581-0708
Re: K072121
Trade/Device Name: Trabecular Metal™ Acetabular Revision System Cemented Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: December 20, 2007 Received: December 26, 2007
Dear Ms. Jenks:
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. Patricia Jenks
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
4072121 510(k) Number (if known):
Device Name:
Trabecular Metal Metabular Revision System Cemented Constrained Liner
Indications for Use:
The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss. soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
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)
Hauuuu V. Ougue FOR M.MELKERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072121
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