MobiliT Cup

K191831 · Corin U.S.A. Limited · LZO · Jan 16, 2020 · Orthopedic

Device Facts

• Record ID: K191831
• Device Name: MobiliT Cup
• Applicant: Corin U.S.A. Limited
• Product Code: LZO · Orthopedic
• Decision Date: Jan 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MobiliT™ Cup is a modular dual-mobility acetabular system for total hip arthroplasty. System comprises metal shell and ECiMa™ (Vitamin E UHMWPE) insert; provides two articulating surfaces: shell-to-insert and insert-to-femoral head. Designed for use with Corin 12/14 femoral stems and compatible CoCr or BIOLOX® delta ceramic heads. Used by orthopedic surgeons in clinical settings to replace hip joint articulation, increase stability, and reduce pain in patients with degenerative conditions or high dislocation risk. Device relies on mechanical articulation to restore joint function.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including static mechanical testing (ISO 7206-12), dynamic testing (EN ISO 21535, ISO 14242-1/2, ASTM F2582-14), and material characterization (ASTM D570, ISO 62).

Technological Characteristics

Modular acetabular cup system; metal shell with ECiMa™ (Vitamin E UHMWPE) insert. Compatible with 12/14 femoral stems and CoCr or BIOLOX® delta ceramic heads. Mechanical articulation principle. Testing standards: ISO 7206-12 (deformation), ASTM D570/ISO 62 (soaking/dilatation), EN ISO 21535 (ROM), ISO 14242-1/2 (wear), ASTM F2582-14 (impingement).

Indications for Use

Indicated for primary or revision total hip arthroplasty in patients with degenerative hip pathologies (osteoarthritis, rheumatoid arthritis), femoral head necrosis, femoral neck fracture, congenital luxation, or high risk of dislocation, provided sufficient bone stock exists.

Regulatory Classification

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.

Predicate Devices

• Serf, Novae® Dual Mobility Cup (K111572)
• Corin, Trinity Acetabular System (K170359)

Reference Devices

• 22mm and 28mm CoCr heads (K110087, K131647, K170359)
• 28mm BIOLOX® delta Ceramic Heads (K103120)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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# 3. 510(k) SUMMARY

| 1. Applicant/Sponsor:<br>Distributor | Corin USA<br>12750 Citrus Park Lane<br>Suite 120,<br>Tampa, Florida 33625<br>Establishment Registration No.: 1056629 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)<br>Global Regulatory Affairs Manager<br>Corin Ltd / Corin USA<br>1 [phone]<br>[e-mail]<br><br>Séverine Siracusa<br>Regulatory Affairs Manager<br>Corin France<br>[phone]<br>[e-mail] |
| 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<br>nonporous uncemented prosthesis (21CFR 888.3353) |

## 8. Legally Marketed Devices to which Substantial Equivalence is claimed:

- o Serf, Novae® Dual Mobility Cup (K111572)
- . Corin, Trinity Acetabular System (K170359)

#### 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.