(269 days)
Not Found
No
The summary describes a mechanical implant (hip replacement system) and its physical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended uses listed describe the treatment of various medical conditions and injuries related to the hip joint, indicating a therapeutic purpose.
No
The device is a hip implant system used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it consists of a metal shell and plastic liner, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a POLARCUP® Dual Mobility System, which is a hip implant. It's a physical device surgically implanted into the body to replace or repair a damaged hip joint.
- Intended Use: The intended use clearly states it's for treating conditions of the hip joint, such as arthritis, fractures, and failed previous surgeries. This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, performing tests on bodily fluids or tissues, or providing diagnostic information about a patient's condition based on such analysis.
The device is a surgical implant used for the treatment of hip joint issues, not for diagnosing them.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWY, JDI
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 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.
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)
Wear Testing, Coating Characterization, Range of Motion Testing, Stress Analysis and Faligue Properties were evaluated for the determination of substantial equivalence.
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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
K110135
OCT 1 4 2011
> We are smith&nephew
Smith & Nephew, Inc. Summary of Safety and Effectiveness
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 10, 2011 |
| Contact Person
Manager | Theresa Leister, Regulatory Affairs Project |
| | T (901) 399-5899
F (901) 566-7816 |
| Name of Device: | POLARCUP® Dual Mobility System |
| Common Name: | Acetabular Component |
| Device Classification Name and Reference: | 21 CFR 888.3358 Hip joint
metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis |
| | 21 CFR 888.3390 Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented
prosthesis. |
| | 21 CFR 888.3350 Hip joint metal/polymer
semi-constrained cemented prosthesis. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LPH, KWY, JDI |
| Predicate Devices: | POLARCUP Dual Mobility System
510(k): K070278
Product Codes: LPH, KWY |
| | VERSAFIT Double Mobility System
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
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Quay for MXM
of Surgical, Orthopedic,
K n 0135