(60 days)
No
The document describes a mechanical implant (hip replacement system) and its materials and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant (hip replacement system) used to treat various medical conditions affecting the hip joint, such as osteoarthritis, rheumatoid arthritis, and fractures, with the aim of restoring function and alleviating symptoms. This directly aligns with the definition of a therapeutic device.
No
This device is a hip implant system (Active Articulation Hip Bearings and G7 Metal Liners) designed for total hip arthroplasty, which is a therapeutic intervention, not a diagnostic one. Its intended uses are for treating existing conditions like joint disease, fractures, and failed arthroplasties.
No
The device description clearly outlines physical components (UHMWPE Active Articulation Bearing, Cobalt-Chromium Alloy Liner) and mechanical testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a hip implant system consisting of bearings and liners. These are surgically implanted devices used to replace or augment a damaged hip joint.
- Intended Use: The intended uses listed are all related to treating conditions of the hip joint through surgical intervention (e.g., osteoarthritis, rheumatoid arthritis, fractures, revision surgery). These are not diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
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
-
- Non-inflammatory 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 of previously failed total hip arthroplasty.
-
- Dislocation risks.
The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.
Product codes
LPH, OQG, KWY, LZO
Device Description
The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.
The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).
The proposed CoCr Liners are compatible with the following devices:
- G7 Acetabular Shells K121874 and K140669
- Biomet E1 Avantage Bearings (38-60mm) - K101336
- ArComXL Active Articulation Bearings (38-60mm) K110555
- G7 Active Articulation Bearings (32 and 36mm) - included in this submission
The proposed Active Articulation Bearings are compatible with 22.2mm femoral heads (K974558/K030555).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Results from mechanical tests and engineering analyses demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of these tests and analyses are listed below.
- Liner axial push-out per ASTM F1820, ASTM F2068 and ISO 7206-6
- Liner lever-out per ASTM F1820, ASTM F2068 and ISO 7206-6
- Liner torque per ASTM F1820, ASTM F2068 and ISO 7206-6
- Wear per engineering analysis
- Fretting and Corrosion per ASTM F1875
- Range of Motion per ISO 21535
- Rim Impingement per ASTM F2582
- Femoral head lever-out per Biomet standard
- Femoral head pull-out per ASTM F1820
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
May 1, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet, Incorporated Ms. Amy Walriven Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581
Re: K150522 Trade/Device Name: G7 Dual Mobility System 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: February 27, 2015 Received: March 2, 2015
Dear Ms. Walriven:
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
1
Page 2 - Ms. Amy Walriven
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. 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 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)
K150522
Device Name
G7 Dual Mobility System
Indications for Use (Describe)
-
- Non-inflammatory 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 of previously failed total hip arthroplasty.
-
- Dislocation risks.
The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended applications.
Type of Use (Select one or both, as applicable)
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 G7 Dual Mobility system 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: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Amy L Walriven
Manager, Regulatory Affairs
Phone: (574) 372-6660
Fax: (574) 372-1683 |
| Date: | February 27, 2015 |
| Subject Device: | Trade Name: G7 Dual Mobility System
Common Name: Acetabular Hip Replacement Components
Classification Name:
• LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous,
Uncemented (21 CFR 888.3358)
• OQG - Hip Prosthesis, Semi-Constrained, Cemented,
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) |
Legally marketed devices to which substantial equivalence is claimed:
- Biomet E1 Avantage Head (K101336) ●
- ArComXL Active Articulation Head (K110555)
- . Stryker MDM (K103233)
- Biomet Tri-Polar (K991990) - Reference
Device Description
The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system
4
is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.
The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).
The proposed CoCr Liners are compatible with the following devices:
- G7 Acetabular Shells K121874 and K140669 ●
- Biomet E1 Avantage Bearings (38-60mm) - K101336
- ArComXL Active Articulation Bearings (38-60mm) K110555 ●
- G7 Active Articulation Bearings (32 and 36mm) - included in this submission
The proposed Active Articulation Bearings are compatible with 22.2mm femoral heads (K974558/K030555).
Intended Use and Indications for Use
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular 1. necrosis.
- Rheumatoid arthritis. 2.
-
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty.
-
- Dislocation risks.
The Active Articulation Hip Bearings and G7 Metal Liners 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: The proposed G7 Dual Mobility system and predicate devices have the same intended use.
- Indications for Use: The proposed G7 Dual Mobility system and predicate devices have the same indications for use.
- Materials: The proposed Active Articulation Heads are composed of the same material (100 kGy E1® or ArComXL) as the predicate Biomet E1 Avantage (K101336) and ArComXL Active Articulation Heads (K110555). The proposed CoCr Liners are composed of the same material (Co-Cr-Mo) as the predicate Stryker MDM liner (K103233).
- Design Features: The proposed G7 Dual Mobility system incorporate similar design features as the predicate devices.
5
BIOMET
- Sterilization: The proposed G7 Dual Mobility system and the predicate devices are provided sterile for single-use.
Summary of Performance Data
Results from mechanical tests and engineering analyses demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of these tests and analyses are listed below.
- Liner axial push-out per ASTM F1820, ASTM F2068 and ISO 7206-6
- Liner lever-out per ASTM F1820, ASTM F2068 and ISO 7206-6
- Liner torque per ASTM F1820, ASTM F2068 and ISO 7206-6 ●
- Wear per engineering analysis
- Fretting and Corrosion per ASTM F1875
- Range of Motion per ISO 21535 ●
- Rim Impingement per ASTM F2582
- . Femoral head lever-out per Biomet standard
- Femoral head pull-out per ASTM F1820
Substantial Equivalence Conclusion
The proposed G7 Dual Mobility system has the same intended use and indications for use as the predicate devices. Performance test data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.