(222 days)
No
The 510(k) summary describes a mechanical hip prosthesis and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The studies focus on mechanical properties and biocompatibility.
Yes
The device is a hip prosthesis, which is implanted to alleviate pain and restore function in a damaged hip joint, thus providing a therapeutic benefit.
No
The device is a hip prosthesis, which is an implant used for hip replacement surgery. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy, including proximal bodies, distal stems, and locking screws, which are implanted during surgery. This indicates a hardware-based medical device, not a software-only one.
No, 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: The provided text describes a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint. It is a physical component implanted into the body.
- Intended Use: The intended use clearly states that the device is for "cementless use in total or partial hip arthroplasty in primary or revision surgery." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided about the device's materials, design, and testing (fatigue, pyrogenicity) further confirms that it is a surgical implant, not an IVD.
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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Product codes
LZO, KWY
Device Description
The M-Vizion Femoral Revision System Extension implants are a range extension to the already cleared M-Vizion Femoral Revision System (K191816 and K170690). The range extension includes proximal bodies with holes and distal stems 4°.
The M-Vizion Femoral Revision System a is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.
The locking screw provided with the subject proximal bodies is the same component cleared with the predicate devices. M-Vizion Femoral Revision System K191816 and K170690.
The proximal body is made of titanium alloy (Ti6A17Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is made of titanium alloy while the locking screw is made of titanium alloy and coated with TiNbN.
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)
Non-Clinical Studies:
- DESIGN VALIDATION and CHARACTERIZATION TESTING:
- M-Vizion Femoral Revision System Design validation
- M-Vizion Femoral Revision System ROM evaluation
- M-Vizion Femoral Revision System Fatigue test of the shaft, neck and modular connection according to IL 07.09.187, worst case evaluations and Test Reports 00812-009683-1 and 00812-009683-2
- 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 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
January 11, 2021
Image /page/0/Picture/1 description: The image contains 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.
Medacta International SA % Chris Lussier Sr. Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K201471
Trade/Device Name: M-Vizion Femoral Revision System Extension 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: December 22, 2020 Received: December 23, 2020
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.
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K201471
Device Name
M-Vizion Femoral Revision System Extension
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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, Sr. Director of Quality and Regulatory, Medacta USA Date Prepared: June 3, 2020 Date Revised: January 4, 2021
II. Device
Device Proprietary Name: | M-Vizion Femoral Revision System Extension |
---|---|
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, K191816, Medacta International SA
Reference predicate: -
M-Vizion Femoral Revision System, K170690, Medacta International SA
-
Revision Femoral Stem, K151739, Limacorporate S.p.A.
IV. Device Description
The M-Vizion Femoral Revision System Extension implants are a range extension to the already cleared M-Vizion Femoral Revision System (K191816 and K170690). The range extension includes proximal bodies with holes and distal stems 4°.
4
The M-Vizion Femoral Revision System a is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.
The locking screw provided with the subject proximal bodies is the same component cleared with the predicate devices. M-Vizion Femoral Revision System K191816 and K170690.
The proximal body is made of titanium alloy (Ti6A17Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is made of titanium alloy while the locking screw is made of titanium alloy and coated with TiNbN.
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.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis. ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Comparison of Technological Characteristics VI.
The M-Vizion Femoral Revision System Extension implants and the predicate devices share the following characteristics:
- indication for use;
- system design; ●
- sizes: ●
- materials; ●
- coating; ●
- biocompatibility; ●
- device usage; ●
- sterilitv:
- shelf life; and ●
- packaging. ●
The M-Vizion Femoral Revision System Extension implants differ from the predicate devices as follow:
- specific component shape .
- final implant lengths .
5
Discussion
Medacta International SA has not made any change to the indication for use, system 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 Femoral Revision System Extension implants to the identified predicate 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 ●
- o M-Vizion Femoral Revision System Design validation
- o M-Vizion Femoral Revision System ROM evaluation
- o M-Vizion Femoral Revision System Fatigue test of the shaft, neck and modular connection according to IL 07.09.187, worst case evaluations and Test Reports 00812-009683-1 and 00812-009683-2
- . 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.
VIII. Conclusion
The information provided above supports that the M-Vizion Femoral Revision System Extension implants are as safe and effective as the predicate devices. Therefore, it is concluded that the M-Vizion Femoral Revision System Extension implants are substantially equivalent to the predicate devices.