(121 days)
No
The summary describes a line extension of acetabular shells and liners, focusing on material properties, geometry, and mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for rehabilitating damaged hips and is intended for use in total hip arthroplasty, which are therapeutic interventions.
No
The device is an acetabular system (implants) used for total hip arthroplasty, which is a treatment for damaged hips, not a tool for diagnosing medical conditions.
No
The device description clearly outlines physical components (acetabular shells and liners) and performance testing related to these physical components, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for surgical implantation in the hip to rehabilitate damaged joints. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as modular acetabular shells and liners, which are components of a hip implant. These are physical devices implanted into the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information about a patient's health status through in vitro testing.
In summary, this device is a surgical implant used for treating hip conditions, not a diagnostic tool used outside the body.
N/A
Intended Use / Indications for Use
The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.
Product codes
LPH, LZO, JDI
Device Description
The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm beyond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hips
Indicated Patient Age Range
skeletally mature individuals
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 Continuum and Trilogy IT Acetabular Shells and the Longevity IT Elevated, Offset, and Oblique Liners met performance requirements.
The Longevity IT Elevated, Offset, and Oblique Liners were evaluated in terms of design and geometry to demonstrate that the devices meet performance requirements and are as safe and effective as their predicate. This information and testing data formed the basis for a determination of substantial equivalence.
Specific Non-clinical Testing Completed:
- . Liner Push-Out Evaluation
- . Liner Lever-Out Evaluation
- Liner Torque-Out Evaluation .
- . Rim Deformation Testing
- Liner Locking Mechanism Strength Analysis
- Anatomic Fatigue Testing .
- Liner Wear Performance .
- Liner Durability and Backside Wear .
- Temperature Effects on Liner Assembly .
- Interaction of MRI with Implants .
- Range of Motion Evaluation .
- . Shell Fatigue and Deformation Evaluation
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
§ 888.3358 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.
102662
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
2011
.. '
Summary of Safety and Effectiveness
APR 1 5 2011
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name
and Reference:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
ি ।
Rebecca M. Brooks Specialist, Regulatory Affairs Telephone: (574) 371-8033 Fax: (574) 372-4605
February 10, 2011
Continuum® and Trilogy® IT Acetabular Systems Longevity® IT Highly Crosslinked Polyethylene Elevated Liners Longevity® IT Highly Crosslinked Polyethylene Offset Liners Longevity® IT Highly Crosslinked Polyethylene Oblique Liners
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
Continuum® and Trilogy® IT Acetabular Systems, manufactured by Zimmer, K091508, cleared 11 September 2009
p. 1 of 3
48
1
Page 2 February 10, 2011
1-103662
Continuum® and Trilogy® IT Acetabular Systems & Longevity® IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K101229, cleared 03 December 2010
Trilogy® Acetabular System Longevity® Liners, manufactured by Zimmer, K990135, cleared 12 July 1999
The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm bevond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.
The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.
The Continuum and Trilogy IT Acetabular Shells and Longevity IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners are manufactured, packaged, and sterilized using
400
- 2 of 3
Device Description:
Intended Use:
Comparison to Predicate Device:
Intended Use:
2
Page 3 February 10, 2011
103662
Performance Data (Nonclinical and/or Clinical):
equivalent materials and processes as their predicates. The subject devices also have the same intended use as their predicates.
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Shells and the Longevity IT Elevated, Offset, and Oblique Liners met performance requirements.
The Longevity IT Elevated, Offset, and Oblique Liners were evaluated in terms of design and geometry to demonstrate that the devices meet performance requirements and are as safe and effective as their predicate. This information and testing data formed the basis for a determination of substantial equivalence.
Specific Non-clinical Testing Completed:
- . Liner Push-Out Evaluation
- . Liner Lever-Out Evaluation
- Liner Torque-Out Evaluation .
- . Rim Deformation Testing
- . Liner Locking Mechanism Strength Analysis
- Anatomic Fatigue Testing .
- Liner Wear Performance .
- Liner Durability and Backside Wear .
- Temperature Effects on Liner Assembly .
- Interaction of MRI with Implants .
- Range of Motion Evaluation .
- . Shell Fatigue and Deformation Evaluation
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
p. 3 of 3
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest feathers. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Zimmer, Inc. % Ms. Rebecca M. Brooks Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708
APR 1 5 2011
Re: K103662
Trade/Device Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI Dated: March 18, 2011 Received: March 21, 2011
Dear Ms. Brooks:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Rebecca M. Brooks
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aky B. R. h
fer
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K103662 510(k) Number (if known):
Device Name:
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems Shells & Longevity IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners
Indications for Use:
The system is indicated for primary or revision surgery in skeletally mature individuals 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 system is intended for use either with or without bone cement in total hip arthroplasty.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
י
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)
| for M.Melkerson | Page 1 of 1 | |
|---|---|---|
| (Division Sign-Off) | ||
| Division/of Surgical, Orthopedic, and Restorative Devices | ||
| 510(k) Number | K103662 |