(147 days)
No
The document describes a mechanical implant (hip replacement liner) and its material properties and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip replacement system, which replaces damaged hip joints to reduce pain and improve mobility, directly treating a medical condition.
No
Explanation: The device is a total hip replacement system, indicated for conditions like osteoarthritis and femoral neck fracture, and is described as a replacement for damaged hip joint articulation. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of highly cross-linked ultra-high molecular weight polyethylene, intended for surgical implantation in the hip joint.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "total hip replacement" and is used to "replace the damaged hip joint articulation or a previously implanted prosthetic hip joint". This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical implant made of "highly cross-linked ultra- high molecular weight polyethylene" that is inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information.
Therefore, the BI-MENTUM™ ALTRX® Dual Mobility System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement in the following conditions: - 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™ ALTRX® Dual Mobility Liners are designed to provide additional stability where there is an unstable joint and are for use in total hip arthroplasty that is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation or a previously implanted prosthetic hip joint in patients where there is evidence of sufficient sound bone to seat and support the components.
The BI-MENTUM™ ALTRX® Dual Mobility Liners are intended for single use only.
Product codes
LZO, MEH
Device Description
The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultra-high molecular weight polyethylene. The liner is mobile (free) in the metallic shell and retained on the prosthetic femoral head.
The BI-MENTUM™ ALTRX® Dual Mobility Liner is compatible with all the stems listed on K181744 as well as all the BI-MENTUM™ cups cleared in K181744. The BI-MENTUM™ ALTRX® Dual Mobility Liner is also compatible with the PINNACLE® Dual Mobility Liner, cleared in K200854.
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
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)
The following tests were performed on the BI-MENTUM™ ALTRX® Dual Mobility Liner to demonstrate of safety and efficacy with the predicate devices:
- Verification of product compatibility
- Standard walking wear testing (per ISO 14242-2)
- Stem-Liner Range of Motion
- Head assembly and retention force (per ASTM F1820-13)
- Impingement testing (per ASTM F2582-20) after accelerated aging (per ASTM F2003-02)
- Post impingement testing lever out testing (per ASTM F1820-13)
- The proposed devices also meet the requirement of bacterial endotoxin testing
No clinical tests were conducted to demonstrate substantial equivalence.
Key results: The subject BI-MENTUM™ ALTRX® Dual Mobility Liner is substantially equivalent to the predicate BI-MENTUM™ Dual Mobility System.
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
§ 888.3353 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
April 28, 2021
Image /page/0/Picture/1 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.
Depuy Ireland UC Floriane Heinrich Regulatory Affairs Project Leader Loughbeg Ringaskiddy Co. Cork. Ireland
Re: K203532
Trade/Device Name: BI-MENTUM™ ALTRX® Dual Mobility Liner 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: April 1, 2021 Received: April 2, 2021
Dear Floriane Heinrich:
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,
Vesa Vuniqi 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
BI-MENTUM™ ALTRX® Dual Mobility Liner
Indications for Use (Describe)
BI-MENTUM™ ALTRX® Dual Mobility System is indicated for total hip replacement in the following conditions: - 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
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
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg |
| Ringaskiddy | |
| Co. Cork, Ireland | |
| Phone number | +334 72792851 |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Floriane Heinrich |
| Date prepared | November 30, 2020 |
| Name of device | |
| Trade or proprietary | |
| name | BI-MENTUM™ ALTRX® Dual Mobility Liner |
| Common or usual name | Total hip prosthesis - Acetabular component |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous |
| uncemented prosthesis | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353 |
| Product Code(s) | LZO, MEH |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | BI-MENTUM™ Dual Mobility System (K181744, cleared December 11, 2018) |
| Reference device: PINNACLE® ALTRX® insert (K072963, cleared January 8, | |
| 2008 and K132959, cleared March 10, 2014) | |
| Reason for 510(k) | |
| submission | Line extension - The subject device is dual mobility liner ALTRX® (ultra-high |
| molecular weight polyethylene) manufactured from DePuy. | |
| Device description | The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultra- |
| high molecular weight polyethylene. The liner is mobile (free) in the metallic | |
| shell and retained on the prosthetic femoral head. | |
| The BI-MENTUM™ ALTRX® Dual Mobility Liner is compatible with all the | |
| stems listed on K181744 as well as all the BI-MENTUM™ cups cleared in | |
| K181744. The BI-MENTUM™ ALTRX® Dual Mobility Liner is also | |
| compatible with the PINNACLE® Dual Mobility Liner, cleared in K200854. | |
| Intended use of the device | BI-MENTUM™ ALTRX® Dual Mobility Liners are designed to provide |
| additional stability where there is an unstable joint and are for use in total hip | |
| arthroplasty that is intended to provide increased patient mobility and reduce pain | |
| by replacing the damaged hip joint articulation or a previously implanted prosthetic | |
| hip joint in patients where there is evidence of sufficient sound bone to seat and | |
| support the components. | |
| The BI-MENTUM™ ALTRX® Dual Mobility Liners are intended for single use | |
| only. | |
| Indications for use | BI-MENTUM™ ALTRX® Dual Mobility Liner 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 are if
bone reconstruction so permits |
4
5
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristics | Subject Device: | ||
| BI-MENTUM™ ALTRX® Dual | |||
| Mobility Liner | Predicate Device: | ||
| SERF BI-MENTUM™ Dual | |||
| Mobility System (K181744) | Reference Device: | ||
| DePuy PINNACLE® ALTRX® | |||
| Acetabular Liners (K072963, | |||
| K132959) | |||
| Intended Use | Total Hip Arthroplasty | Same | Same |
| Liner Material | UHMWPE, GUR 1020 | UHMWPE, GUR 1050 | UHMWPE, GUR 1020 |
| Fixation | Uncemented | Same | Same |
| Dual Mobility | Yes | Yes | No |
| Dual Mobility | |||
| Design | Monobloc dual articulation | Monobloc dual articulation | N/A |
| Compatible | |||
| Acetabular Shell | |||
| Diameters | 41 - 69 mm | Same | 44 - 76 mm |
| Internal Diameter | |||
| of Dual Mobility | |||
| Liner | 22.2 mm, 28 mm | Same | 28, 32, 36, 40, 44 and 48 mm |
| Sterile Method | Gas Plasma | Gamma | Gas Plasma |
| Sterility Assurance | |||
| Level | 10-6 | 10-6 | 10-6 |
| Packaging | Double PETG blister with Tyvek peel | ||
| lid | Vacuum-packed in bags and sealed in | ||
| blister packaging | Double PETG blister with Tyvek | ||
| peel lid | |||
| Shelf Life | 5 years | Same | Same |
| The subject BI-MENTUM™ ALTRX® Dual Mobility Liner has the same intended use and fixation as the predicate BI-MENTUM™ Dual | |||
| Mobility System (K181744). The subject device is intended for total hip arthroplasty; is a dual mobility construct and is available in the same | |||
| size range as the predicate device. The subject BI-MENTUM™ ALTRX® Dual Mobility Liner has the same intended use and the same materia | |||
| (UHMWPE GUR 1020) as the reference device DePuy PINNACLE® ALTRX® Acetabular Liners (K072963, K132959). |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the BI-MENTUM™ ALTRX® Dual Mobility Liner to demonstrate of safety and efficacy with the predicate devices:
- . Verification of product compatibility
- Standard walking wear testing (per ISO 14242-2) .
- Stem-Liner Range of Motion .
- Head assembly and retention force (per ASTM F1820-13) .
- Impingement testing (per ASTM F2582-20) after accelerated aging (per ASTM F2003-02) .
- Post impingement testing lever out testing (per ASTM F1820-13) .
- The proposed devices also meet the requirement of bacterial endotoxin testing .
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIV ALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject BI-MENTUM™ ALTRX® Dual Mobility Liner is substantially equivalent to the predicate BI-MENTUM™ Dual Mobility System.