(191 days)
Not Found
No
The summary describes a mechanical hip implant system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a hip implant, which is a medical device designed to treat or prevent a disease (e.g., osteoarthritis, rheumatoid arthritis) or to affect the structure or function of the body (e.g., replace a hip joint).
No
The device is a MobiliT™ Cup, which is described as a modular system for hip replacement surgery. Its intended use is for primary and revision total hip arthroplasty, and it is a therapeutic device designed to replace a hip joint, not diagnose a condition.
No
The device description clearly states it is a physical implantable device (metal shell with an insert) used in hip replacement surgery, not a software program.
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 replacing the hip joint in various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a modular system of metal and polyethylene components designed to be implanted in the hip joint. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
Therefore, the MobiliT™ Cup is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MobiliT™ 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
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) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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 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.
Clinical testing was not necessary to determine substantial equivalence between the MobiliT™ Cup and the predicate devices.
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.
Serf, Novae® Dual Mobility Cup (K111572), Corin, Trinity Acetabular System (K170359)
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.
Not Found
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
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
1
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 USA
12750 Citrus Park Lane
Suite 120,
Tampa, Florida 33625
Establishment Registration No.: 1056629 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)
Global Regulatory Affairs Manager
Corin Ltd / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com
Séverine Siracusa
Regulatory Affairs Manager
Corin France
+33 (0)4 56 60 89 78
severine.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 on
nonporous 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) .
4
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.