(191 days)
The MobiliTTM Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint:
- In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis
- -For patients who have a high risk of dislocation
- In cases of necrosis of the femoral head -
- In cases of fracture of the neck of the femur -
- In cases of congenital luxation -
The MobiliTTM Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.
The cementless MobiliTTM standard Cup, with flanges and hook are indicated for cementless use only.
The cemented MobiliT™ Cup is indicated for cemented use only.
The MobiliT™ Cup is a modular system consisting of two articulating surfaces in the same joint space. The MobiliT™ Cup is a metal shell combined with a specific ECiMa™ insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless with ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) insert. A Trinity™ femoral head 22mm or 28mm CoCr, or a 28mm BIOLOX® delta articulates within the ECiMa™ insert to allow for a second articulation. The MobiliTTM Cup is designed for use with any Corin 12/14 femoral stem.
The MobiliT™ Cup is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The MobiliT™ Cup is intended to be used with the following approved devices:
This is a medical device 510(k) clearance document for the MobiliT™ Cup, a hip prosthesis. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain a table of acceptance criteria with specific numerical targets and corresponding device performance metrics. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The acceptance is based on the new device performing comparably to the predicate devices in various required tests.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Static Tests | |
| Push-out strength | Met "substantially equivalent" to predicate devices |
| Pull-out strength | Met "substantially equivalent" to predicate devices |
| Lever-out strength | Met "substantially equivalent" to predicate devices |
| Deformation (ISO 7206-12) | Met "substantially equivalent" to predicate devices |
| Soaking (ASTM D570 & ISO 62) | Met "substantially equivalent" to predicate devices |
| Dilatation (ASTM D570 & ISO 62) | Met "substantially equivalent" to predicate devices |
| Dynamic Tests | |
| Range of Motion (EN ISO 21535) | Met "substantially equivalent" to predicate devices |
| Wear (ISO 14242-1/2) | Met "substantially equivalent" to predicate devices |
| Impingement Test (ASTM 2582-14) | Met "substantially equivalent" to predicate devices |
| Biocompatibility | |
| Bacterial Endotoxin Testing (BET) | Conducted using LAL kinetic chromogenic methodology; results imply compliance with safety standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as "sample size." The testing is described as "Non-Clinical Testing and Analysis," which typically involves a set number of physical samples of the device being tested according to standardized methods. The specific number of devices or components tested for each experiment (e.g., how many cups were subjected to push-out tests) is not provided.
- Data Provenance: The data comes from non-clinical bench testing performed by the manufacturer (Corin USA Limited or its affiliates). There is no mention of country of origin for the testing data beyond the manufacturer's location. The tests are not retrospective or prospective in the clinical sense, as no human or animal subjects were involved.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. For a medical device 510(k) clearance based solely on non-clinical (bench) testing, there are no "experts used to establish ground truth" in the way one would for clinical image interpretation or diagnosis. The "ground truth" for these engineering tests is established by adhering to recognized international and ASTM standards (e.g., ISO 7206-12, ASTM D570, ISO 14242-1/2, ASTM 2582-14). Compliance is assessed by engineers and regulatory bodies against these standards.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical endpoints. This document describes non-clinical engineering tests where the results are objective measurements against established standards, not subjective interpretations requiring adjudication.
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:
- No. An MRMC comparative effectiveness study was not conducted. This is a hip prosthesis, not an AI-powered diagnostic device designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a physical medical implant (hip prosthesis), not an algorithm or AI device. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for the non-clinical tests is based on engineering standards and specifications (e.g., the force required to reach a specific deformation, wear rates within acceptable ranges as defined by ISO standards). The results are objective measurements against established pass/fail criteria derived from these standards and comparison to predicate device performance.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this 510(k) submission. Training sets are relevant for machine learning algorithms, which is not what this device is. The development of the device likely involved engineering design, prototyping, and iterative testing, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. (See point 8).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
January 16, 2020
Corin USA Limited Severine Siracusa Regulatory Affairs Manager, Corin France 12750 Citrus Park Lane Tampa, Florida 33625
Re: K191831
Trade/Device Name: MobiliT™ Cup 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, MEH Dated: December 13, 2019 Received: December 16, 2019
Dear Severine Siracusa:
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
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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,
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
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510(k) Number (if known): K191831
Device Name: MobiliT™ Cup
Indications for Use:
The MobiliTTM Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint:
- In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis
- -For patients who have a high risk of dislocation
- In cases of necrosis of the femoral head -
- In cases of fracture of the neck of the femur -
- In cases of congenital luxation -
The MobiliTTM Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.
The cementless MobiliTTM standard Cup, with flanges and hook are indicated for cementless use only.
The cemented MobiliT™ Cup is indicated for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1_
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3. 510(k) SUMMARY
| 1. Applicant/Sponsor:Distributor | Corin USA12750 Citrus Park LaneSuite 120,Tampa, Florida 33625Establishment Registration No.: 1056629 |
|---|---|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)Global Regulatory Affairs ManagerCorin Ltd / Corin USA1 (772) 321-2478lucinda.gerber@coringroup.comSéverine SiracusaRegulatory Affairs ManagerCorin France+33 (0)4 56 60 89 78severine.siracusa@coringroup.com |
| 3. Date: | December 13rd, 2019 |
| 4. Proprietary Name: | MobiliT™ Cup |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | LZO, MEH |
| 7. Classification Name: | Hip joint metal/ceramic/ polymer semi-constrained cemented onnonporous uncemented prosthesis (21CFR 888.3353) |
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
9. Device Description:
The MobiliT™ Cup is a modular system consisting of two articulating surfaces in the same joint space. The MobiliT™ Cup is a metal shell combined with a specific ECiMa™ insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless with ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) insert. A Trinity™ femoral head 22mm or 28mm CoCr, or a 28mm BIOLOX® delta articulates within the ECiMa™ insert to allow for a second articulation. The MobiliTTM Cup is designed for use with any Corin 12/14 femoral stem.
The MobiliT™ Cup is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The MobiliT™ Cup is intended to be used with the following approved devices:
- 22mm and 28mm CoCr heads (K110087, K131647 and K170359) ●
- 28mm BIOLOX® delta Ceramic Heads (K103120) .
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10. Intended Use / Indications:
The MobiliT™ Cup, for cemented and cementless use, are indicated for primary replacement of the hip ioint:
- In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis
- For patients who have a high risk of dislocation ।
- In cases of necrosis of the femoral head -
- In cases of fracture of the neck of the femur -
- -In cases of congenital luxation
The MobiliT™ Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.
The cementless MobiliT™ standard Cup, with flanges and hook are indicated for cementless use only.
The cemented MobiliT™ Cup is indicated for cemented use only.
11. Summary of Technologies/Substantial Equivalence:
The MobiliT™ Cup is similar to the predicate devices Serf, Novae® Dual Mobility Cup (K111572) and Corin, Trinity Acetabular System (K170359) in terms of design material, size, intended use and indications of use.
Based on these similarities, the MobiliT™ Cup is believed to be substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing and analysis for the MobiliT™ Cup conducted to demonstrate substantial equivalence includes Static tests (Push-out, pull-out, lever-out, deformation (ISO7206-12), soaking and dilatation (ASTM D570 & ISO62)) and Dynamic Tests (Range of motion (EN ISO 21535), wear (ISO14242-1/2) and impingement test (ASTM2582-14)).
The results of this tests show that the MobiliT™ Cup is substantially equivalent to the predicate devices.
Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the MobiliT™ Cup and the predicate devices.
§ 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.