(261 days)
No
The document describes a mechanical implant (hip replacement component) and its physical performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a component of a total hip prosthesis, indicated for the treatment of various degenerative joint diseases, fractures, and for revision procedures, all of which aim to alleviate symptoms, restore function, or correct deformities.
No
The device is described as a component of a total hip prosthesis, specifically a constrained liner, used in primary and revision total hip arthroplasty (THA). Its intended uses are for the treatment of various joint conditions and functional deformities, not for diagnosing them. The performance studies listed are tests of material integrity and mechanical properties, not diagnostic accuracy.
No
The device description clearly states it is a physical component (a constrained liner made of polyethylene and titanium alloy) for a total hip prosthesis, and the performance studies involve physical testing of this component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device for surgical implantation to treat various conditions of the hip joint, such as osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a component of a total hip prosthesis, specifically a constrained liner for an acetabular system. This is a physical implant designed to replace or augment a part of the hip joint.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Performance Studies: The performance studies listed focus on mechanical properties, wear, range of motion, and imaging compatibility of the implant, which are relevant to a surgical device, not a diagnostic test.
In summary, the device is a surgical implant for hip replacement, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.
Indications for G7® Vivacit-E® Freedom® Constrained Liner:
The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or 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)
PBI, JDI, KWZ, LPH, LZO, OOG, OQH, OQI
Device Description
The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.
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
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)
Following performance testing/evaluation were performed for the subject liner and are included in this 510(k) submission -
- Minimum Dynamic Insertion Energy Required to . Seat G7 ® Vivacit-E ® Freedom ® Constrained Liner
- G7® Vivacit-E® Freedom® Constrained Liner Torque Out Evaluation, Freedom Femoral Head Push-in and Pull-out forces from G7 ® Vivacit-E ® Freedom® Constrained Liner
- Freedom Femoral Head Lever Out from G7 ® Vivacit-E® Freedom® Constrained Liner
- Disassembly of the G7 ® Vivacit-E ® Freedom ® ● Constrained Liner Construct via Lever-Out
- Disassembly of the 36mm G7 ® Vivacit-E ® . Freedom® ® Constrained Liner Construct via Lever-Out
- In-Vitro Wear Testing of the G7 ® Vivacit-E ® ● Freedom® Constrained Liner
- Constraining Ring Disassembly from the G7 ® . Vivacit-E® Freedom® Constrained Liner
- Evaluation of G7 ® Vivacit-E ® Freedom® Constrained Liner in the Magnetic Resonance (MR) Imaging Environment
- Anatomic Fatigue Testing of G7 ® Vivacit-E ® . Freedom® Constrained Liner
- Rim Impingement Testing of G7 ® Vivacit-E ® ● Freedom® Constrained Liner
- G7® Vivacit-E® Freedom® Constrained Liner ● Range of Motion
- G7® Vivacit-E® Freedom® Constrained Liner . Lever-Out Test
- In-Vitro Wear Testing of the G7 ® Vivacit-E ® Freedom® Constrained Liners in the Presence of Abrasive Particles
The performance testing/evaluation and the biological safety risk assessment included in this 510(k) submission demonstrates that the subject liner is at least as safe and effective as the predicate 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2022
Zimmer, Inc. Adam Haas Regulatory Affairs Senior Specialist 1800 W. Center Street Warsaw, Indiana 46580
Re: K212512
Trade/Device Name: G7® Vivacit-E® Freedom® Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Or Uncemented Prosthesis Regulatory Class: Class II Product Code: PBI, JDI, KWZ, LPH, LZO, OOG, OQH, OQI Dated: April 1, 2022 Received: April 1, 2022
Dear Adam Haas:
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
1
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 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 (OS) 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,
Limin Sun, Ph.D. 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) K212512
Device Name
G7® Vivacit-E® Freedom® Constrained Liner
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
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.
Indications for G7® Vivacit-E® Freedom® Constrained Liner:
The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
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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510(k) Summary
| Sponsor: | Zimmer, Inc.
1800 W. Center Street
Warsaw, IN 46580
Establishment Registration Number: 1822565 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Adam Haas
Regulatory Affairs Senior Specialist
Telephone: (908-361-7475)
Adam.Haas@zimmerbiomet.com |
| Date: | April 27, 2022 |
| Subject Device: | Trade Name: G7 ® Vivacit-E ® Freedom ® Constrained
Liner |
| | Primary Classification Name: |
| | • PBI - Prosthesis, Hip, Constrained, Cemented or
Uncemented, Metal/Polymer, + Additive (21 CFR
888.3310 - Hip joint metal/polymer constrained
cemented or uncemented prosthesis) |
| | Additional Classification Names: |
| | • JDI - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Cemented (21 CFR 888.3350 – Hip
joint metal/polymer semi-constrained cemented
prosthesis)
• KWZ - Prosthesis, Hip, Constrained, Cemented Or
Uncemented, Metal/Polymer (21 CFR 888.3310 – Hip
joint metal/polymer constrained cemented or
uncemented prosthesis)
• LPH - Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Porous Uncemented (21 CFR 888.3358
– Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis)
• LZO - Prosthesis, Hip, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented (21 CFR 888.3353 – Hip joint
metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis) |
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- · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented (21 CFR 888.3358 - Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis)
- · OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented (21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis)
- · OOI Hip. Semi-Constrained. Cemented. Metal/Ceramic/Polymer + Additive, Porous Uncemented (21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis)
| 510(k) Number | Device Name | Applicant |
|---|---|---|
| K121874 (primary) | G7 E1® Freedom | Biomet |
| and K142882 | Constrained Liner | Orthopedics |
Reference Predicate:
Predicate Device(s):
| 510(k) Number | Device Name | Applicant |
|---|---|---|
| K071718 | Trilogy Longevity | |
| Constrained Liner | Zimmer, Inc. |
Device Description:
The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.
5
Indications for Use:
1 ) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head
involvement, unmanageable by other techniques 5) Revision procedures where other treatment or devices have failed
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.
Indications for G7® Vivacit-E® Freedom® Constrained Liner:
The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Same as the predicate device.
- Indications for Use: Same as the predicate device. ●
- Variants/Sizes: Same as the predicate device.
- Design Features: Similar to the predicate device
- . Material: The constraining ring and plug materials are same as the predicate device. The polyethylene materials used for the subject and the predicate devices are both Vitamin E infused highly crosslinked ultra high molecular weight polyethylenes. The two polyethylene materials use the same resin (GUR1020) but have different concentrations of Vitamin E and different manufacturing processes.
- Sterility: Same as the predicate device. ●
- Shelf Life: Same as the predicate device.
Summary of Technological Characteristics:
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Summary of Performance Data (Nonclinical and/or Clinical):
Following performance testing/evaluation were performed for the subject liner and are included in this 510(k) submission -
- Minimum Dynamic Insertion Energy Required to . Seat G7 ® Vivacit-E ® Freedom ® Constrained Liner
- G7® Vivacit-E® Freedom® Constrained Liner Torque Out Evaluation, Freedom Femoral Head Push-in and Pull-out forces from G7 ® Vivacit-E ® Freedom® Constrained Liner
- Freedom Femoral Head Lever Out from G7 ® Vivacit-E® Freedom® Constrained Liner
- Disassembly of the G7 ® Vivacit-E ® Freedom ® ● Constrained Liner Construct via Lever-Out
- Disassembly of the 36mm G7 ® Vivacit-E ® . Freedom® ® Constrained Liner Construct via Lever-Out
- In-Vitro Wear Testing of the G7 ® Vivacit-E ® ● Freedom® Constrained Liner
- Constraining Ring Disassembly from the G7 ® . Vivacit-E® Freedom® Constrained Liner
- Evaluation of G7 ® Vivacit-E ® Freedom® Constrained Liner in the Magnetic Resonance (MR) Imaging Environment
- Anatomic Fatigue Testing of G7 ® Vivacit-E ® . Freedom® Constrained Liner
- Rim Impingement Testing of G7 ® Vivacit-E ® ● Freedom® Constrained Liner
- G7® Vivacit-E® Freedom® Constrained Liner ● Range of Motion
- G7® Vivacit-E® Freedom® Constrained Liner . Lever-Out Test
- In-Vitro Wear Testing of the G7 ® Vivacit-E ® Freedom® Constrained Liners in the Presence of Abrasive Particles
Substantial Equivalence Conclusion:
The intended use, indications for use, variants, sizes, materials (for the constraining ring and the plug). sterilization method, and shelf life of the subject liner are same as that of the predicate device. There are differences in the design features and material between the subject liner and the predicate device. However, these differences do not
7
raise new questions of safety and/or effectiveness. The performance testing/evaluation and the biological safety risk assessment included in this 510(k) submission demonstrates that the subject liner is at least as safe and effective as the predicate device. Therefore, it is concluded that the G7® Vivacit-E® Freedom ® Constrained Liner is substantially equivalent to the predicate device.