(112 days)
The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.
The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, a polyethylene liner and optional screws. The shells with screw holes permit the use of Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
This document is a 510(k) premarket notification for the "Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems," which are components of a total hip prosthesis. The notification focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not directly available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a device like an AI algorithm are present in this document. This submission is for a medical device (hip prosthesis) and focuses on mechanical and biological performance, primarily through non-clinical testing and comparison to predicate devices, rather than a diagnostic or AI-driven system.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable - This document is a 510(k) for a medical device (hip prosthesis) focusing on substantial equivalence, not an AI/diagnostic device with numerical performance criteria. | Not applicable |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable. This submission doesn't describe a "test set" in the context of an AI or diagnostic algorithm's performance evaluation on patient data. The non-clinical testing would involve physical samples of the device.
- Data Provenance: Not applicable. The document discusses non-clinical testing of the physical device, not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on image interpretation, pathology reports) is not relevant to this type of device submission. The "ground truth" for a hip prosthesis would be its mechanical integrity and biocompatibility, assessed through laboratory tests and manufacturing controls.
4. Adjudication method for the test set:
Not applicable. There is no specific "adjudication method" mentioned for a test set of patient data, as this is not an AI/diagnostic device submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic or interpretation device, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used:
Not applicable in the context of AI/diagnostic algorithms. For this medical device, the "ground truth" would be established by validated engineering principles, material science standards, and biocompatibility testing.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" involved.
Summary of the Study Discussed (Non-Clinical Performance):
The document states:
- "Non-Clinical Performance and Conclusions: Non-Clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Systems met performance requirements and are as safe and effective as their predicates."
This indicates that the study performed was non-clinical (laboratory testing) and aimed to show that the new device's performance was equivalent to that of existing, legally marketed predicate devices. The "performance requirements" would refer to mechanical properties (e.g., strength, durability, fatigue resistance) and potentially other material-specific tests relevant to an orthopedic implant. The specific details of these "performance requirements" and the results are not elaborated upon in this summary document but would have been part of the full 510(k) submission.
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SEP 1 1 2009
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The logo is black and white.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Benjamin Curson, CQE RAC Associate Project Manager, Regulatory Affairs Telephone: (574) 372-4119 Fax: (574) 372-4605
May 21, 2009
Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems
Total Hip Prosthesis
LPH - Prosthesis, Hip, Semi-constrained, metal/polymer, porous, uncemented; 21 CFR 888.3358
JDI - Prosthesis, Hip, Semi-constrained, metal/polymer, cemented; 21 CFR 888.3350
LZO - Prosthesis, Hip, Semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented; 21 CFR 888.3353
Trabecular Metal Acetabular System, manufactured by Zimmer, Inc. (K021891), Trilogy Acetabular System, manufactured by Zimmer, Inc. (K934765). Converge Acetabular System, manufactured by Zimmer, Inc. (K012739), Trilogy Acetabular System Large Head Liner, manufactured by Zimmer, Inc. (K002960), and Trilogy Acetabular System 46mm Large Head Liners, manufactured by Zimmer, Inc. (K003478)
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Page 2 May 21, 2009
Device Description:
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, a polyethylene liner and optional screws. The shells with screw holes permit the use of Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.
The Continuum and Trilogy IT Acetabular Systems are packaged, manufactured, and sterilized using the same materials and processes as their predicates. The subject device also has the same intended use and fixation methods as the predicate device.
Non-Clinical Performance and Conclusions:
Non-Clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Systems met performance requirements and are as safe and effective as their predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
SEP 1 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Mr. Benjamin Curson, CQE, RAC Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw. Indiana 46581-0708
Re: K091508
Trade/Device Name: Continuum and Trilogy Integrated Taper Acetabular Systems Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class: II Product Code: LPH, LZO, JDI
Dated: August 11, 2009 .
Received: August 12, 2009
Dear Mr. Curson:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 - Mr. Benjamin Curson, CQE, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Daibare Sneetp
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name:
Continuum and Trilogy Integrated Taper (IT) Acetabular systems
Indications for Use:
The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The devices are intended for use either with or without bone cement.
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)
Quta for mxn
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number KD91508
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.