POLARCUP DUAL MOBILITY SYSTEM

K110135 · Smith & Nephew, Inc. · LPH · Oct 14, 2011 · Orthopedic

Device Facts

• Record ID: K110135
• Device Name: POLARCUP DUAL MOBILITY SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The POLARCUP® Dual Mobility System is indicated for: - Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis. - Fracture or avascular necrosis of the femoral head . - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement - . All forms of osteoarthritis - . Patients with hips at risk of dislocation - Femoral neck fracture or proximal fracture to hip joint . The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Device Story

Acetabular component for total hip arthroplasty; dual mobility design features metal shell with polished inner surface and articulating plastic liner. Increases intra-prosthetic stability to reduce dislocation risk. Implanted by orthopedic surgeons in clinical/surgical settings. Subject device expands size range and adds highly crosslinked polyethylene liners to previously cleared system. Provides mechanical hip joint reconstruction; benefits patients requiring revision or at high risk of recurrent dislocation.

Clinical Evidence

Bench testing only. Evaluated via wear testing, coating characterization, range of motion testing, stress analysis, and fatigue properties to confirm ability to withstand in vivo loading.

Technological Characteristics

Metal shell with polished inner surface; highly crosslinked polyethylene liner. Dual mobility articulation. Uncemented or cemented versions. Single-use. Class II device.

Indications for Use

Indicated for patients with advanced hip degeneration (arthritis, post-traumatic), femoral head fracture/avascular necrosis, failed prior hip surgery, osteoarthritis, or high risk of dislocation (including elderly).

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• POLARCUP Dual Mobility System (K070278)
• VERSAFIT Double Mobility System (K083116)

Submission Summary (Full Text)

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# K110135

OCT 1 4 2011

# > We are smith&nephew

### Smith & Nephew, Inc. Summary of Safety and Effectiveness

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 10, 2011 |
| Contact Person<br>Manager | Theresa Leister, Regulatory Affairs Project |
| | T [phone]<br>F [phone] |
| Name of Device: | POLARCUP® Dual Mobility System |
| Common Name: | Acetabular Component |
| Device Classification Name and Reference: | 21 CFR 888.3358 Hip joint<br>metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis |
| | 21 CFR 888.3390 Hip joint femoral (hemi-hip)<br>metal/polymer cemented or uncemented<br>prosthesis. |
| | 21 CFR 888.3350 Hip joint metal/polymer<br>semi-constrained cemented prosthesis. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LPH, KWY, JDI |
| Predicate Devices: | POLARCUP Dual Mobility System<br>510(k): K070278<br>Product Codes: LPH, KWY |
| | VERSAFIT Double Mobility System<br>510(k): K083116 |

#### Device Description

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. This dual mobility design results in higher intra-prosthetic stability to address the treatment of patients with a high risk of dislocation (especially for elderly patients) or patients with

Product Code: MEH

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K110135 (pg. 2 of 2)

recurrent dislocation. The subject device is identical to the previously cleared POLARCUP® Dual Mobility System with the exception of an increase in the size range and the addition of Highly Crosslinked Polyethylene Liners.

#### Technological Characteristics

A review of the mechanical data indicates that the POLARCUP® Dual Mobility System is capable of withstanding expected in vivo loading without failure.

#### Intended Use

The POLARCUP® Dual Mobility System is indicated for:

- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head .
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, � hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- . All forms of osteoarthritis
- . Patients with hips at risk of dislocation
- Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

#### Substantial Equivalence Information

The overall design, materials, and indications for use for the POLARCUP® Dual Mobility System are substantially equivalent to the commercially available predicate devices identified.

Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis and Faligue Properties were evaluated for the determination of substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OCT 1 4 2011

Smith & Nephew, Inc. Orthopaedic Division % Ms. Theresa Leister Regulatory Affairs Project Manager 1450 East Brooks Road Memphis. Tennessee 38116

Re: K110135 Trade/Device Name: POLARCUP Dual Mobility System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, KWY, JDI Dated: October 10, 2011 Received: October 13, 2011

Dear Ms. Leister:

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.

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 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

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Page 2 - Ms. Theresa Leister

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin D. Keith

Jor 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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# Premarket Notification Indications for Use Statement

510(k) Number (if known): _K110135

Device Name: POLARCUP® Dual Mobility System

Indications for Use:

The POLARCUP® Dual Mobility System is indicated for:

- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or . rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head ●
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
- All forms of osteoarthritis .
- Patients with hips at risk of dislocation .
- Femoral neck fracture or proximal fracture to hip joint .

The POLARCUP® Dual Mobility System is intended for single use only and depending on its version is to be implanted either with or without bone cement.

Prescription Use X AND/OR Over-the-Counter Use (Part 21 CFR 801.109) (Optional Format 1-2-96)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Quay for MXM

of Surgical, Orthopedic,

K n 0135