(76 days)
Not Found
No
The document describes a modular acetabular cup system for hip replacement and does not mention any AI or ML components or functionalities. The performance studies focus on MR compatibility, not algorithmic performance.
Yes.
The device is a medical implant (total hip arthroplasty system) used for rehabilitating damaged hips, which fits the definition of a therapeutic device.
No
Explanation: The device is an acetabular cup system intended for hip replacement surgery. Its purpose is to repair or replace damaged hip joints, not to diagnose medical conditions. The mention of "noninflammatory degenerative joint disease (NID) or its composite diagnoses" indicates conditions the device is used to treat, not conditions it diagnoses.
No
The device description clearly states it is a modular acetabular cup system consisting of physical components like shells, plugs, and liners, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a hip joint damaged by various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modular acetabular cup system designed for surgical implantation. This aligns with a medical device used in surgery, not a device used to test samples from the body.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical implant used to treat a condition through surgery.
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 (NID) 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 (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO
Device Description
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, optional dome and screw hole plugs, and highly cross-linked polyethylene (HXPE) liners. The shells with screw holes permit the use of previously cleared Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient. The dome and screw hole plugs may be placed by the surgeon into any unused holes in the shell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
The Continuum and Trilogy IT Acetabular Systems have been evaluated for compatibility in the MR environment per Guidance for Industry and FDA Staff,"Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Based upon the results, the subject device is recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.
Clinical Performance and Conclusions:
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.
K091508, K093846, K101229, K103662
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.
Not Found
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
§ 888.3358 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Zimmer, Inc. Mr. Paul Hardy Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K151448
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, JDI, LZO Dated: June 12, 2015 Received: June 15, 2015
Dear Mr. Hardy:
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 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
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K151448 (page 1/1)
Device Name
Continuum and Trilogy Integrated Taper (IT) Acetabular systems
Indications for Use (Describe)
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 (NID) 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue. The logo is simple and modern, with a focus on the company's name and a distinctive initial.
P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131
Summary of Safety and Effectiveness Sponsor: Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 Contact Person: Paul Hardy Specialist, Regulatory Affairs Telephone: (574) 372-4257 Fax: (574) 372-4605 August 11, 2015 Date: Trade Name: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems including: Continuum IT and Trilogy IT Shells Longevity IT Highly Crosslinked Polyethylene Neutral Liners Longevity IT Highly Crosslinked Polyethylene Elevated Liners Product Codes / Device: LPH, JDI, LZO Regulation Number / Description: 21 CFR § 888.3358- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 21 CFR § 888.3350- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 21 CFR § 888.3353- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous. Uncemented Predicate Devices: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems, manufactured by Zimmer, K091508, cleared September 11, 2009 Longevity IT Highly Crosslinked Polyethylene Elevated Liners, manufactured by Zimmer, K093846, cleared February 4, 2010
4
| | Longevity Integrated Taper (IT) Highly Crosslinked
Polyethylene Elevated Liners, Continuum and
Trilogy Integrated Taper (IT) Acetabular System
Shells, manufactured by Zimmer, K101229, cleared
December 3, 2010 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Continuum and Trilogy Integrated Taper Highly
Crosslinked Polyethylene Elevated, Offset, &
Oblique Liners, manufactured by Zimmer,
K103662, cleared April 15, 2011 |
| Device Description: | 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, optional
dome and screw hole plugs, and highly cross-linked
polyethylene (HXPE) liners. The shells with screw
holes permit the use of previously cleared Tivanium
alloy screws to provide additional fixation and
security, particularly in those cases where
acetabular bone stock is deficient. The dome and
screw hole plugs may be placed by the surgeon into
any unused holes in the shell. |
| Intended 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. |
| Comparison to Predicate Device: | This submission is for a labeling modification. The
labeling modification consists of the addition of
Magnetic Resonance Imaging (MRI) compatibility
information to the Package Insert, and the
application of the "MR Conditional" symbol on the
package label. |
| Performance Data (Nonclinical | Non-Clinical Performance and Conclusions: |
5
and/or Clinical):
The Continuum and Trilogy IT Acetabular Systems have been evaluated for compatibility in the MR environment per Guidance for Industry and FDA Staff,"Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Based upon the results, the subject device is recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.