(226 days)
The Versafitcup™ 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
The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648. There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system. The polyethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafitcup™ Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).
This document describes the premarket notification (510(k)) for the Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, a hip joint prosthesis component. The focus of the submission is on demonstrating substantial equivalence to a predicate device, which is primarily achieved through performance testing and comparison of material properties and design.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table detailing "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for software or diagnostic devices. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with various international standards and FDA guidance documents. | Testing results met all pre-defined acceptance criteria. |
| Physical and mechanical properties similar to standard UHMWPE. | "The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE..." |
| Increased resistance to wear compared to standard UHMWPE. | "...has increased resistance to wear as shown in simulator wear data" |
| Substantial equivalence to predicate device (K083116) in intended use, raw material, manufacturing method, design, sizes, dimensions, mating components, sterilization, and packaging. | The submission asserts and FDA concurs that the device is substantially equivalent to the predicate device in these aspects. |
| Compliance with ASTM F648 for highly crosslinked UHMWPE. | "The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "testing was conducted on the worst case component size and option/design." No specific numerical sample size is provided for the performance testing.
- Data Provenance: The data is generated from in vitro performance testing (e.g., "simulator wear data") conducted by the manufacturer, Medacta International SA. It is not patient or clinical data. The country of origin of the data would be where Medacta International SA performed the testing, which is Switzerland. The data is retrospective in the sense that it describes the performance of the manufactured product under test conditions, not prospective clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This criterion is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the device's performance is established through objective engineering and material science testing against predefined standards and specifications, not through expert consensus on medical images or diagnoses. There's no mention of experts establishing ground truth for the test set.
4. Adjudication Method for the Test Set
This criterion is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases (e.g., radiology reads) to establish a consensus ground truth. The performance testing for this orthopedic implant relies on objective measurements from instruments and protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This criterion is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or assessment of AI assistance improvement for human readers was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This criterion is not applicable. The device itself is a physical medical device. There is no "algorithm" to be tested in a standalone manner without human-in-the-loop performance. The testing performed is on the physical properties and wear characteristics of the implant material.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the device's performance is based on:
- Material Specifications and Standards: Compliance with ASTM F648 for highly crosslinked UHMWPE.
- Engineering Performance Benchmarks: Comparison of physical and mechanical properties to standard UHMWPE and demonstration of increased wear resistance through simulator testing.
- Design and Manufacturing Consistency: Ensuring the new liners maintain the same design, sizes, dimensions, functionality, and manufacturing methods as the predicate device.
8. The Sample Size for the Training Set
This criterion is not applicable. There is no "training set" in the context of an AI/machine learning model. The device is a physical product, and its development and validation rely on engineering design, material science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
This criterion is not applicable as there is no training set for an AI/machine learning model.
In summary: The provided document describes the regulatory submission for a physical medical device (hip joint liner). The performance testing and acceptance criteria are rooted in material science, engineering standards, and direct comparison to a predicate device's established characteristics, rather than clinical efficacy studies, expert consensus on images, or AI algorithm validation methods.
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K092265- II'/3
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, followed by a plus sign.
Traditional 510(k) Summary
MAR 1 2 2010
MEDACTA International SA Manufacturer: Strada Reqina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX
Ms. Natalie J. Kennel Contact Person: 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
Sept. 24, 2009 Date Prepared:
DEVICE INFORMATION
| Trade/Proprietary Name: | Versafitcup™ Double Mobility Highcross®HXUHMWPE Liners |
|---|---|
| Common Name:Classification Name: | Total Joint ReplacementHip Joint, metal/ceramic/polymer semi-constrainedcemented or non-porous uncemented prosthesis |
| 21 CFR 888.3353Class IIDevice Product Code: MEH | |
| Predicate Devices: | K083116 Versafitcup™ Double Mobility SystemK071718 Trilogy Longevity Constrained LinerK061253 Reflection 3 Acetabular SystemK030923 Epsilon™ Durasul® ConstrainedAcetabular liner |
Versafitcup™ DM HXUHMWPE Liners 510(k)
Section 5 - Page 2 of 4
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K092265 #2
K021911 Trident® Crossfire® Polyethylene Liners K994415 DePuy Marathon™ Crosslinked Polvethylene Acetabular Cup Liners K990135 Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners
Product Description:
The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648.
There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system.
The polyethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafitcup™ Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. Th
The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).
Indications for Use:
The Versafitcup™ 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, . traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
- Congenital hip dysplasia .
- Ankvlosing spondylitis .
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck .
Versafitcup™ DM HXUHMWPE Liners 510(k)
Section 5 - Page 3 of 4
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K092265 #3/3
- Failure of previous hip surgery, joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- 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 Versafitcup™ Double Mobility Highcross® HXUHMWPE liners was conducted in accordance with various international standards and FDA guidance documents.
The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners were tested as part of design verification to written protocols with pre-defined acceptance criteria. As applicable, 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 Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are substantially equivalent to the predicate device.
Basis of Substantial Equivalence
The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners have the following similarities to the standard UHMWPE liners cleared in K083116: same intended use, same raw material, same method of manufacture, same design, same sizes and dimensions, same mating components, and same sterilization and packaging methods. The new highly crosslinked liners have an increased resistance to wear as shown in simulator wear data. These in vitro results have not been correlated to clinical experience. The method of highly crosslinking of the UHMWPE is similar to that used in other cleared total hip replacement systems.
Conclusion:
The data and information provided in this submission support the conclusion that the Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are substantially equivalent to its predicate device, Versafitcup™ Double Mobility family with respect to intended use, design, and operational principles. The use of highly crosslinked UHMWPE is similar to that used in other cleared total hip replacement systems.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Medacta International, SA % NJK & Associates, Inc. Ms. Natalie Kennel 13721 Via Tres Vista San Diego, California 92129
MAR 1 2 2010
Re: K092265
Trade/Device Name: Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners 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: MEH Dated: February 23, 2010 Received: February 26, 2010
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. 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
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Page 2 – Ms. Natalie Kennel
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Akbarmeup
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K092265
Device Name: Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners
Indications for Use:
The Versafitcup™ 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 _____________________________________________________________________________________________________________________________________________________________
OR Over-The-Counter Use
(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)
Smithe for mxn
(Division Signer)
Division of Servical, Orthopedic, and Restorative Devices
Page of
510(k) Number K092265
§ 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.