(162 days)
Not Found
No
The device description focuses on the materials and mechanical components of a hip replacement system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a component of a total hip replacement system, which is used to treat medical conditions like osteoarthritis and femoral neck fractures, thereby providing therapeutic benefit.
No
Explanation: The BI-MENTUM™ Dual Mobility System is a surgical implant used for total hip replacement procedures. Its purpose is to replace a damaged hip, not to diagnose a condition. The detailed description of its components and intended use clearly indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of metallic materials and polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The BI-MENTUM™ Dual Mobility System is a total hip replacement system. It is an implantable device used to replace damaged hip joints. This is a surgical procedure performed directly on the patient's body, not on a specimen taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes.
Therefore, the BI-MENTUM™ Dual Mobility System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes:
- Osteoarthritis
- Femoral neck fracture
- Dislocation risk
- Osteonecrosis of the femoral head
- Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUMTM Cemented Cup is indicated for cemented use.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The BI-MENTUM™ dual mobility system is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell
- BI-MENTUM™ Cemented Cup: the cemented metallic shell is made of stainless steel according to ISO 5832- 1. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell
The cementless metallic shell is made of stainless steel according to ISO 5832-1 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available:
- BI-MENTUM™ PressFit Cup: this version is available without the pegs and screw, and is a press fit only.
- BI-MENTUM™ Plus Cup: it has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
- BI-MENTUM™ Revision Cup: it has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
Liner
The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws
When applicable, primary fixation can be reinforced by impacted pegs and self-tapping cortical screws made of stainless steel according to ISO 5832-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (acetabulum, femoral head)
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)
Non-clinical Test Summary:
BI-MENTUM™ dual mobility system is the same product as NOVAE® Dual Mobility Acetabular Cup cleared in 2011 (K111572, SERF). There is no change in the design of the acetabular cup, no change in the fundamental scientific technology of the device. However new cup/head + stem assembly were validated.
The following tests were conducted:
- Head insertion on force and Head Pull-Out testing (acceptance criteria was met) .
- Range of motion analysis (acceptance criteria was met) .
- . Wear Analysis (acceptance criteria was met)
Clinical Test Summary:
No clinical studies were performed
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
December 11, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Serf % Catherine Gloster Founder and Principal Consultant Gloster Biomedical International 577 N Hope Avenue Santa Barbara. California 93110
Re: K181744
Trade/Device Name: BI-MENTUM™ dual mobility system Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: October 17, 2018 Received: October 22, 2018
Dear Catherine Gloster:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.12.11 12:15:09 -05'00'
For 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) K181744
Device Name
BI-MENTUM™ Dual Mobility System
Indications for Use (Describe)
BI-MENTUM™ Dual Mobility System is indicated for total hip replacement, which includes:
-
Osteoarthritis
-
Femoral neck fracture
-
Dislocation risk
-
Osteonecrosis of the femoral head
-
Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUMTM Cemented Cup is indicated for cemented use.
| 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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3
510(k) Summary
Date: June 27th, 2018
| Company name and address: | SERF
85 avenue des Bruyères
69153 Décines Cedex
FRANCE
Phone: +33 4 72 05 60 10
Fax: +33 4 72 02 19 18 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact person: | Jean-Luc AURELLE
General Manager |
| Date prepared: | June 27th, 2018 |
| Trade name: | BI-MENTUMTM dual mobility system |
| Common name: | Total hip prosthesis - Acetabular component |
Hip joint metal/ceramic/polymer semi-constrained cemented or Classification name: nonporous uncemented prosthesis (21 CFR 888.3353, Product Code LZO/MEH)
Device description
The BI-MENTUM™ dual mobility system is composed of a metallic shell fixed in the acetabulum and a polyethylene liner.
Cemented metallic shell
- BI-MENTUM™ Cemented Cup: the cemented metallic shell is made of stainless steel according to ISO 5832- 1. The outer surface is sandblasted and presents macro-volumes to augment contact between the implant and the cement. The inner surface is highly polished.
Cementless metallic shell
The cementless metallic shell is made of stainless steel according to ISO 5832-1 and is coated with a CP titanium and hydroxyapatite plasma spray (double layer coating) on the outer surface and is highly polished on the inner surface.
Three cementless metal-backs are available:
-
BI-MENTUM™ PressFit Cup: this version is available without the pegs and screw, and is a press fit only.
-
BI-MENTUM™ Plus Cup: it has 3 fixation points (2 divergent pegs towards the pubis and ischium and 1 cortical screw through a flange towards the ilium).
-
BI-MENTUM™ Revision Cup: it has 5 fixation points (2 divergent pegs towards the pubis and ischium, cortical screws through 2 flanges towards the ilium and 1 foramen hook).
4
Liner
The liner is made of Ultra-High-Molecular-Weight Polyethylene according to ISO 5834-2. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head. Liners can be used with Ø22,2 or 28 mm prosthetic femoral heads.
Pegs and cortical screws
When applicable, primary fixation can be reinforced by impacted pegs and self-tapping cortical screws made of stainless steel according to ISO 5832-1.
Substantial equivalence claimed to predicate devices
BI-MENTUM™ dual mobility system is the same product as NOVAE® Dual Mobility Acetabular Cup cleared in 2011 (K111572, SERF).
There is no change in the design of the acetabular cup, no change in the fundamental scientific technology of the device. Newly validated cup/head + stem assembly are substantially equivalent to the NOVAE® Dual Mobility Acetabular Cup yet validated assembly (K111572, SERF) in terms of mechanical safety and performances.
| Device | BI-MENTUM™ dual mobility system | NOVAE® Dual Mobility Acetabular Cup |
|---|---|---|
| 510(k) number | / | K111572 |
| Intended use | ||
| Total hip replacement | Yes | Yes |
| Cemented/Cementless | Yes/Yes | Yes/Yes |
| Primary/Revision | Yes/Yes | Yes/Yes |
| Design | ||
| Dual mobility | Yes | Yes |
| Metal-back and a mobile liner | Yes | Yes |
| Screws | Cortical | Cortical |
| Pegs | Grooved | Grooved |
| Liner is retained on the head | Yes | Yes |
| Materials | ||
| Metal-back | Stainless steel (ISO 5832-1) | Stainless steel (ISO 5832-1) |
| Metal-back coating | Commercially pure titanium | |
| and hydroxyapatite | Commercially pure titanium | |
| and hydroxyapatite | ||
| Liner | Liner: UHMWPE (ISO 5834-2) | Liner: UHMWPE (ISO 5834-2) |
| Screws and Pegs | Stainless steel (ISO 5832-1) | Stainless steel (ISO 5832-1) |
Intended use
BI-MENTUM™ dual mobility system is indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- Dislocation risk .
- Osteonecrosis of the femoral head .
- . Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
5
BI-MENTUM™ PressFit Cup, BI-MENTUM™ Plus Cup and BI-MENTUM™ Revision Cup are intended for press-fit use and BI-MENTUM™ Cemented Cup is indicated for cemented use.
Non-clinical Test Summary
BI-MENTUM™ dual mobility system is the same product as NOVAE® Dual Mobility Acetabular Cup cleared in 2011 (K111572, SERF). There is no change in the design of the acetabular cup, no change in the fundamental scientific technology of the device. However new cup/head + stem assembly were validated.
The following tests were conducted:
- Head insertion on force and Head Pull-Out testing (acceptance criteria was met) .
- Range of motion analysis (acceptance criteria was met) .
- . Wear Analysis (acceptance criteria was met)
Clinical Test Summary
No clinical studies were performed
Conclusions Nonclinical and Clinical
BI-MENTUM™ dual mobility system is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and performances.