(301 days)
No
The summary describes a hip prosthesis and its material properties and dimensions. There is no mention of AI, ML, or any software component that would utilize such technologies.
Yes
The device is a hip prosthesis, which is implanted to replace a diseased or damaged hip joint, directly treating and alleviating conditions like severe pain, arthritis, and necrosis, thereby restoring function and improving the patient's quality of life.
No
The M-Vizion hip prosthesis is designed for surgical implantation in hip replacement procedures, not for identifying a medical condition or disease.
No
The device description clearly describes a physical hip prosthesis made of metallic materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing conditions like arthritis, avascular necrosis, and fractures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (a hip prosthesis stem) made of metallic materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY
Device Description
The M-Vizion Monobloc is a range extension to the already cleared M-Vizion Femoral Revision System (K201471, K191816 and K170690).
The M-VIZION Monobloc Stem is a monobloc cementless stem intended to be used for hip arthroplasty, in primary or revision surgeries. It shows a fluted tapered distal portion made of forged Ti-6Al-7Nb alloy according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6- Aluminium 7-Niobium Alloy coated with a titanium coating. TiGrowth®-C (Medacta commercial name: Mectagrip); a proximal portion coated with Titanium Ti ASTM F 1580 and it is sandblasted distally.
The available size are:
- Length L190 mm ø12-26 mm STD/LAT;
- Length L240 mm ø12-26 mm STD/LAT;
- Length L290 mm ø12-26 mm STD/LAT.
The two versions STD/LAT have the following geometrical details: - STD: CCD angle 132°, offset 37 mm;
- LAT: CCD angle 132°, offset 43 mm.
The M-VIZION Monobloc Stem is a range extension of the M-VIZION Modular Stem, from which it leverages most of the geometrical features such as the stem taper angle, the flutes design, the shape of the neck and proximal portion, and the Ti coating. Differently from the M-VIZION Monobloc Stem, the M- VIZION Modular Stem includes also a Locking Screw to fix the two parts.
The M-VIZION Monobloc Stems are substantially equivalent to Medacta primary predicate M-Vizion Femoral Revision System (K201471, K191816 and K170690) and to the secondary competitor predicate device Zimmer Biomet, Wagner SL Revision Stem (K953689, K043356).
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 (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)
Non-Clinical Studies:
- DESIGN VALIDATION and CHARACTERIZATION TESTING
- Performance Tests
- Range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -Joint Replacement Implants - Specific Requirements For Hip-Joint Replacement Implants:
- M-Vizion neck worst case (FEM): ASTM F2996-13 Standard Practice for Finite Element Analysis of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- M-Vizion shaft worst case (FEM): ASTM F2996-13 Standard Practice for Finite Element Analysis of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- PYROGENICITY:
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted.
Key Results: The information provided supports that the M-Vizion Monobloc implants are as safe and effective as the predicate devices. Therefore, it is concluded that the M-Vizion Monobloc implants are substantially equivalent to the predicate devices.
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.
K201471, K191816, K170690, K953689, K043356, K113556
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
May 24, 2022
Medacta International S.A. % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K212327
Trade/Device Name: M-Vizion Monobloc 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, KWY Dated: April 20, 2022 Received: April 22, 2022
Dear Chris Lussier:
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.
1
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 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 medical devices and radiation-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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name M-Vizion Monobloc
Indications for Use (Describe)
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
| 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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2.0 510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: July 26, 2021 Date Revised: May 20, 2022
II. Device
| Device Proprietary Name: | M-Vizion Monobloc |
|---|---|
| Common or Usual Name: | Hip Prosthesis |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, |
| Cemented or Non-Porous, Uncemented | |
| Primary Product Code: | LZO |
| Secondary product code | KWY |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary Predicate:
M-Vizion Femoral Revision System Extension, K201471, Medacta International SA
Secondary Predicate:
-
M-Vizion Femoral Revision System Extension, K191816, Medacta International SA
-
M-Vizion Femoral Revision System, K170690, Medacta International SA
- Wagner SL Revision Stem K953689, Zimmer Biomet A
-
Wagner SL Revision Stem Lateral K043356, Zimmer Biomet
- A Wagner Cone Prosthesis System K113556, Zimmer Biomet
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Device Description IV.
The M-Vizion Monobloc is a range extension to the already cleared M-Vizion Femoral Revision System (K201471, K191816 and K170690).
The M-VIZION Monobloc Stem is a monobloc cementless stem intended to be used for hip arthroplasty, in primary or revision surgeries. It shows a fluted tapered distal portion made of forged Ti-6Al-7Nb alloy according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6- Aluminium 7-Niobium Alloy coated with a titanium coating. TiGrowth®-C (Medacta commercial name: Mectagrip); a proximal portion coated with Titanium Ti ASTM F 1580 and it is sandblasted distally.
The available size are:
- Length L190 mm ø12-26 mm STD/LAT; .
- Length L240 mm ø12-26 mm STD/LAT;
- Length L290 mm ø12-26 mm STD/LAT. ●
The two versions STD/LAT have the following geometrical details:
- STD: CCD angle 132°, offset 37 mm; .
- LAT: CCD angle 132°, offset 43 mm. ●
The M-VIZION Monobloc Stem is a range extension of the M-VIZION Modular Stem, from which it leverages most of the geometrical features such as the stem taper angle, the flutes design, the shape of the neck and proximal portion, and the Ti coating. Differently from the M-VIZION Monobloc Stem, the M- VIZION Modular Stem includes also a Locking Screw to fix the two parts.
The M-VIZION Monobloc Stems are substantially equivalent to Medacta primary predicate M-Vizion Femoral Revision System (K201471, K191816 and K170690) and to the secondary competitor predicate device Zimmer Biomet, Wagner SL Revision Stem (K953689, K043356).
V. Indications for Use
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
- . Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck. ●
5
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
VI. Comparison of Technological Characteristics
The M-VIZION Monobloc implants and the predicate devices share the following characteristics:
- indication for use; ●
- design:
- sizes: ●
- . materials:
- coating:
- biocompatibility: ●
- device usage:
- sterility: ●
- shelf life: and
- packaging. ●
The M-VIZION Monobloc implants differ from the primary predicate devices as follow:
- it is monobloc
- no locking screw to fix the two components. ●
Discussion
Medacta International SA has not made any change to the indication for use, design, materials, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the M-Vizion Monobloc implants to the identified predicate devices.
The only differences between the subject and the primary predicate devices is the fact that now the stem is a monobloc cementless stem and for this reason no locking screw is required to fix the two components. These differences don't introduce any worst case from a clinical point of view or regarding the biomechanical performance of the implants. The new feature has been designed in order to increase the product range. This technological difference does not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject device design.
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Biocompatibility evaluation provided for Medacta's predicate device M-Vizion Femoral Revision System (K201471, K191816 and K170690) for the same materials support the biological safety of the M-Vizion Monobloc devices.
VII. Performance Data
Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION and CHARACTERIZATION TESTING ●
- . Performance Tests
- o Range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -Joint Replacement Implants - Specific Requirements For Hip-Joint Replacement Implants:
- o M-Vizion neck worst case (FEM): ASTM F2996-13 Standard Practice for Finite Element Analysis of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- o M-Vizion shaft worst case (FEM): ASTM F2996-13 Standard Practice for Finite Element Analysis of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is equivalent to USP chapter )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted. ●
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Medacta International SA
VIII. Conclusion
The information provided above supports that the M-Vizion Monobloc implants are as safe and effective as the predicate devices. Therefore, it is concluded that the M-Vizion Monobloc implants are substantially equivalent to the predicate devices.