(259 days)
No
The summary describes a mechanical implant (acetabular shell and liners) and its intended use and performance testing, with no mention of AI or ML.
Yes
The device is an implantable medical device designed for total hip arthroplasty to treat severely painful and/or disabled joints, avascular necrosis, fractures, and failures of previous hip surgeries, thus providing a therapeutic effect by improving joint function and alleviating pain.
No
This device is an implantable medical device (acetabular shell and liners) used in total hip arthroplasty, which is a treatment for severe joint pain and disability. It is not designed to diagnose a condition.
No
The device description clearly states that the devices are "implantable medical devices" and lists physical components like "Acetabular Shell" and "Double Mobility HC liners." This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implantable medical device for use in total hip arthroplasty surgery. This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as an "implantable medical device." IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Performance Studies: The performance studies described are related to the mechanical properties, wear, range of motion, fatigue, and biocompatibility of the implantable device. These are typical tests for surgical implants, not for diagnostic tests performed on specimens.
- No mention of analyzing biological specimens: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological specimen.
Therefore, the Versacem Acetabular Shell and Double Mobility HC Liners are not IVDs. They are implantable surgical devices.
N/A
Intended Use / Indications for Use
Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polvarthritis 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
- Elderly patients or poor bone quality.
- Revision for recurrent dislocation in elderly patients with poor bone quality.
- Patients treated with radiotherapy or chemotherapy.
Versacem is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The purpose of this submission is to gain clearance for the Versacem Acetabular Shell and to add two new sizes of the compatible Double Mobility HC Liners previously cleared within K092265, K131458 and K143453.
The Versacem Acetabular Shell implants and the Double Mobility HC liners are sterile, individually packaged, implantable medical devices intended to be used in Total Hip Arthroplasty.
The devices subject of this submission are:
- Versacem Acetabular Shell from size Ø40 to size Ø56;
- Double Mobility HC liner Ø22.2/DMAZ;
- Double Mobility HC liner Ø28/DMC.
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)
Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests are provided in support of the substantial equivalence determination.
Nonclinical Studies
DESIGN VALIDATION
- Versacem Acetabular Shell and double Mobility HC Liner Design Validation
PERFORMANCE TESTING
- Versacem Acetabular Shell and Double Mobility HC Liners Wear Test
- Versacem Acetabular Shell - Range of Motion Evaluation
- Versacem Acetabular Shell Fatigue Test
- Double Mobility HC Liner – Pull-off and Lever-out Tests
- Versacem Acetabular Shell Evaluation of Jumping Distance
- Versacem Acetabular Shell Evaluation of impingement risk
PYROGENICITY
Control of pyrogenicity is validated through the following primary test methods on all identified representative devices as part of their initial validation prior to submission:
- Quantification of bacterial endotoxin units (EU) on the device surface after final cleaning and sterilization using the bacterial endotoxin test (LAL test) on the basis of a measured colourproducing reaction proportional to the interaction of Limulus amebocyte lysate (LAL) and endotoxin according to ISO11737-3 and European Pharmacopoeia 2.6.14 (which is harmonized with USP chapter and USP )
- In-vivo evaluation of pyrogenicity in rabbit, per USP , in conjunction with biocompatibility studies.
BIOCOMPATIBILITY assessment
SHELF-LIFE evaluation
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.
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.
K092265, K131458, K143453, K091967
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
March 6, 2025
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141
Re: K241767
Trade/Device Name: Versacem Acetabular Shell and Double Mobility HC 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: LZO Dated: February 7, 2025 Received: February 7, 2025
Dear Christopher 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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the text "Limin Sun -S" in a large, bold, sans-serif font. The text is black against a white background. The words are arranged horizontally, with "Limin" on the left, followed by "Sun" and then "-S". The text appears to be a title or heading. The background has a light blue watermark.
Limin Sun, Ph.D. 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
3
Indications for Use
Submission Number (if known)
Device Name
Versacem Acetabular Shell and Double Mobility HC Liners
Indications for Use (Describe)
Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polvarthritis 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
- · Elderly patients or poor bone quality.
- · Revision for recurrent dislocation in elderly patients with poor bone quality.
- · Patients treated with radiotherapy or chemotherapy.
Versacem is intended for cemented use only.
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)
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."
4
Medacta International SA
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, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: June 18, 2024 Date Revised: February 07, 2025
II. Device
| Device Proprietary Name: | Versacem Acetabular Shell and Double Mobility HC Liners |
|---|---|
| Common or Usual Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, |
| Cemented Or Non-Porous, Uncemented | |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis. | |
| Primary Product Code | LZO |
| Regulation Number: | 21 CFR 888.3353 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices.
Primary Predicate device:
-
. NOVAE® Stick Dual Mobility Acetabular Cup, K111572, Serf
Reference predicate devices: -
Double Mobility HighCross® highly crosslinked UHMWPE, K092265, Medacta International SA
-
Double Mobility HighCross® highly crosslinked UHMWPE, K131458, Medacta International SA
-
Double Mobility HighCross highly crosslinked UHMWPE Liners, K143453, Medacta International SA
-
Medacta Bipolar Head, K091967, Medacta International SA
5
Medacta International SA
IV. Device Description
The purpose of this submission is to gain clearance for the Versacem Acetabular Shell and to add two new sizes of the compatible Double Mobility HC Liners previously cleared within K092265, K131458 and K143453.
The Versacem Acetabular Shell implants and the Double Mobility HC liners are sterile, individually packaged, implantable medical devices intended to be used in Total Hip Arthroplasty.
The devices subject of this submission are:
- . Versacem Acetabular Shell from size Ø40 to size Ø56;
- . Double Mobility HC liner Ø22.2/DMAZ;
- Double Mobility HC liner Ø28/DMC. ●
V. Indications for Use
Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:
- . Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, theumatoid 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, partial hip ● arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
- . Elderly patients or poor bone quality.
- Revision for recurrent dislocation in elderly patients with poor bone quality.
- Patients treated with radiotherapy or chemotherapy. .
Versacem is intended for cemented use only.
VI. Comparison of Technological Characteristics
The subject Versacem Acetabular Shell and the predicate device NOVAE® Stick Dual Mobility Acetabular Cup (K111572) are substantially equivalent with respect to the following characteristics:
- General Design; ●
- Articular surface; ●
- Cementation; ●
- Material: ●
- Biocompatibility;
- Device usage ●
- Packaging ●
6
The subject Versacem Acetabular Shell and the predicate device NOVAE® Stick Dual Mobility Acetabular Cup (K111572) differ with respect to the following characteristics:
- . Range of sizes;
- Shelf-life; .
- Sterilization method. ●
Discussion
The slight difference between subject and predicate devices range of sizes do not pose any new risk in terms of safety and performance as evaluated in the bench testing.
The subject device shelf-life does not affect in any way its safety and performance, as it is shared with the predicate device Medacta Bipolar Head (K091967) and in general with the majority of Medacta products cleared in US. The Medacta Bipolar Head (K091967) is substantially equivalent to the subject device in terms of manufacturing material and main steps of the production process.
Finally, the subject device sterilization method do not arise any new risk in terms of safety and performance as it is fully validated.
The subject Double Mobility HC liners are substantially equivalent to the predicate devices Double Mobility HC Liners (K092265; K131458; K143453) with respect to the following characteristics:
- Design:
- Articular Surface; ●
- Material; ●
- Biocompatibility: ●
- Device Usage;
- Packaging; ●
- Shelf-life: ●
- Sterilization method. ●
The subject Double Mobility HC liners differ from the predicate devices Double Mobility HC Liners (K092265; K131458; K143453) with respect to the following characteristics:
- Range of sizes. ●
Discussion
The difference between subject and predicate devices range of sizes do not pose any new risk in terms of safety and performance as the inner diameter of subject and predicate devices is the same. The difference in the outer diameter between subject and predicate device do not pose any new risk in terms of safety and performance as evaluated in the bench testing.
VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests are provided in support of the substantial equivalence determination.
Nonclinical Studies
7
DESIGN VALIDATION
- Versacem Acetabular Shell and double Mobility HC Liner Design Validation ●
PERFORMANCE TESTING
- Versacem Acetabular Shell and Double Mobility HC Liners Wear Test ●
- . Versacem Acetabular Shell - Range of Motion Evaluation
- Versacem Acetabular Shell Fatigue Test ●
- Double Mobility HC Liner – Pull-off and Lever-out Tests
- Versacem Acetabular Shell Evaluation of Jumping Distance ●
- Versacem Acetabular Shell Evaluation of impingement risk ●
PYROGENICITY
Medacta International does not intend to label the subject devices as non-pyrogenic or pyrogen free. Control of pyrogenicity is validated through the following primary test methods on all identified representative devices as part of their initial validation prior to submission:
-
- Quantification of bacterial endotoxin units (EU) on the device surface after final cleaning and sterilization using the bacterial endotoxin test (LAL test) on the basis of a measured colourproducing reaction proportional to the interaction of Limulus amebocyte lysate (LAL) and endotoxin according to ISO11737-3 and European Pharmacopoeia $2.6.14 (which is harmonized with USP chapter and USP )
-
- In-vivo evaluation of pyrogenicity in rabbit, per USP , in conjunction with biocompatibility studies.
BIOCOMPATIBILITY assessment
SHELF-LIFE evaluation
VIII. Conclusion
The information provided above supports that the subject devices are substantially equivalent to the predicate devices.