(267 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implantable system (Dual Mobility Hip Bearings) used to treat various degenerative joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure medical conditions.
No
The device description and intended use indicate it is an implantable medical device (hip bearing system) for treatment and revision surgeries, not for diagnosing conditions.
No
The device description clearly details physical components (polyethylene bearing, femoral head, metal liner, acetabular shell) and the performance studies focus on mechanical testing of these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Dual Mobility Hip Bearing" system, which are "single-use implants." These are surgically implanted devices used to replace or augment a hip joint.
- Intended Use: The intended uses listed are all related to treating conditions of the hip joint through surgical implantation, not through testing bodily samples.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
- Dislocation risks.
Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.
Product codes (comma separated list FDA assigned to the subject device)
LPH, OQG, KWY, LZO
Device Description
The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include a polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Tests: Mechanical testing and engineering analysis was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. The test reports are listed below:
- Push In / Pull Out Testing
- Lever Out Testing
- Anatomic Fatigue Testing
- Rim Impingement Testing
- Range of Motion Evaluation
- Laser Etch Verification
- Wear Justification
- MRI compatibility
- Shelf Life Justification
- Dimensional Stability Justification
Clinical Tests: Clinical data was not deemed necessary for the subject 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.
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.
0
December 6, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Zimmer Inc. Charles Neitzel Senior Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K190656
Trade/Device Name: Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings 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, OQG, KWY, LZO Dated: November 6, 2019 Received: November 7, 2019
Dear Charles Neitzel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Indications for Use (Describe)
- · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Correction of functional deformity.
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- · Revision procedures where other treatment or devices have failed.
- · Dislocation risks.
Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Dual Mobility Longevity and Vivacit-E Hip Bearings 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charles Neitzel
Specialist, Regulatory Affairs
Telephone: (262) -716-3243
Fax: (574) 372-4605 |
| Date: | 13-March-2019 |
| Subject Device: | Trade Name: Dual Mobility Longevity and Vivacit-E
Polyethylene Hip Bearings
Common Name: Hip Prosthesis
Classification Name:
LPH - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Porous Uncemented (21 CFR 888.3358)OQG - Prosthesis, hip, semi-constrained,
metal/polymer + additive, porous uncemented (21 CFR 888.3358)KWY - Prosthesis, Hip, Hemi-, Femoral,
Metal/Polymer, Cemented Or Uncemented (21 CFR 888.3390)LZO - Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353) |
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K161190 G7 Dual Mobility Biomet Inc. System, Active Articulation System Secondary Predicates K151448 Continuum And Trilogy Zimmer Inc. Integrated Taper (IT) Acetabular Systems K120370 Continuum-Trilogy IT Zimmer Inc. Acetabular System: Vivacit-E Vitamin E Highly Crosslinked Polyethylene IT Neutral and Elevated Liners Purpose and Device Description: The purpose of this subject 510(k) is to introduce a new set of acetabular bearings within the G7 Dual Mobility and Active Articulation Systems. There are no changes to the other components within the systems. The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include a polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced. Intended Use and Indications for Use: . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. ● Rheumatoid arthritis. Correction of functional deformity. ● . Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head
Primary Predicates
Predicate Device(s):
involvement, unmanageable by other techniques.
- . Revision procedures where other treatment or devices have failed.
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- . Dislocation risks.
Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to the predicates ●
- Indications for Use: Same as the G7 Dual Mobility . System and Active Articulation System predicates, similar to the Continuum/Trilogy IT predicate
- . Materials: Same polyethylene material as the Continuum/Trilogy IT predicate
- Design Features: Identical to the G7 Dual Mobility . System and Active Articulation System predicates, similar to the Continuum/Trilogy IT predicate
- Sterilization: Same as the Continuum/Trilogy IT predicate
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests: Mechanical testing and engineering analysis was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. The test reports are listed below:
- Push In / Pull Out Testing O
- O Lever Out Testing
- O Anatomic Fatigue Testing
- Rim Impingement Testing O
- o Range of Motion Evaluation
- Laser Etch Verification O
- Wear Justification O
- MRI compatibility O
- Shelf Life Justification O
- Dimensional Stability Justification O
- Clinical Tests: ●
o Clinical data was not deemed necessary for the subject device.
Substantial Equivalence
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Conclusion
The subject device has the same intended use and the same indications for use as the G7 Dual Mobility System and Active Articulation System predicate devices. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate that:
- any differences do not raise new questions of safety . and effectiveness; and
- . the proposed device is at least as safe and effective as the legally marketed predicate devices.
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