(168 days)
No
The 510(k) summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on mechanical testing and equivalence to predicate devices.
No.
The device is an orthopedic implant for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint, not a therapeutic device in the sense of actively delivering therapy.
No
The device is an acetabular component for total hip arthroplasty, which is a treatment for painful and/or disabled joints, not a diagnostic tool.
No
The device description clearly states it is a two-piece modular designed device consisting of a metal acetabular shell and a polyethylene liner, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty. This is a medical device used in vivo (within the body) for treatment.
- Device Description: The description details the materials and design of a physical implant (metal shell and polyethylene liner) intended to be surgically placed in the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Versafit Cup Double Mobility Acetabular Component Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- . Severely painful and/or disabled joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- 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 where sufficient bone stock is present.
- Dislocation risks .
Product codes
MEH
Device Description
The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm.
The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation.
The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature
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)
Performance testing of the Versafit Cup Double Mobility Family was conducted in accordance with various international standards and FDA guidance documents.
The Versafit Cup Double Mobility family was tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K072857, K073337, K080885, K082792
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
11083116 (pg 1/3)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a bold, sans-serif font, with a stylized graphic above the first letter. Below the word "Medacta" is the word "International" in a smaller font, and to the right of that is a symbol that looks like a plus sign.
510(k) Summary
APR - 7 2009
Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 FAX (+41) 91 696 60 66
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Date Prepared: February 20, 2009
DEVICE INFORMATION
Trade/Proprietary Name: Versafit Cup Double Mobility Family
Common Name: Total Joint Replacement /Classification Name: Hip Joint, metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis
21 CFR 888.3353 Class II Device Product Code: MEH
Predicate Devices:
K070278 POLARCUP® Dual Mobility System K072020 Restoration ™ ADM System
Product Description:
The Versafit Cup Double Mobility Acetabular Component is a two piece modular designed device consisting of the metal acetabular shell and a
Versafit Cup Double Mobility 510(k)
Section 5 - Page 2 of 4
1
mating polyethylene liner. The metal component is machined from stainless steel M30NW conforming to ISO 5832-9. The outer surface of the metallic cup has two types of coatings: Ti plasma spray and HA/Ti plasma spray. The polyethylene liner is a double mobility liner made of standard UHMWPE conforming to ISO 5834. The liner has a minimum thickness of 5 mm. The acetabular component is available in 10 sizes which accept both CoCrMo and MectaCer BIOLOX forte Ceramic ball heads with diameters of 22 and 28 mm.
The polvethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafit cup Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation.
The Versafit Cup Double Mobility Family is designed to be used with the Medacta Total Hip Prosthesis' Quadra S Stems and ball heads (K072857, K073337, K080885, K082792).
Indications for Use:
The Versafit Cup Double Mobility Acetabular Component Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- . Severely painful and/or disabled joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- 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 where sufficient bone stock is present.
- Dislocation risks .
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the Versafit Cup Double Mobility Family was conducted in accordance with various international standards and FDA guidance documents.
The Versafit Cup Double Mobility family was tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performance of
Versafit Cup Double Mobility 510(k)
Section 5 - Page 3 of 4
2
the Versafit Cup Double Mobility family is substantially equivalent to the predicate devices.
Conclusion:
The data and information provided in this submission support the conclusion that the Versafit Cup Double Mobility Family are substantially equivalent to its predicate devices, POLARCUP® Dual Mobility System and Restoration™ ADM System with respect to intended use, design, materials, and operational principles.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medacta International, SA % NJK & Associates, Inc. Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, CA 92129
APR - 7 2009
Re: K083116
Trade/Device Name: Versafit Cup Double Mobility Family Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH Dated: March 30, 2009 Received: April 3, 2009
Dear Ms. Kennel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set
4
Page 2 – Ms. Natalie J. Kennel
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K083116
Device Name: Versafit Cup Double Mobility Family
Indications for Use:
The Versafit Cup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature. The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint as a result of osteoarthritis, post ● traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
- Congenital hip dysplasia .
- Ankylosing spondylitis .
- 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.
- Dislocation risks �
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carlae Busein Dor
Page · of
Division of General, Restorative. and Neurological Devices
510(k) Number K083116