(206 days)
No
The document describes a mechanical implant (femoral stem) and its material properties and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral stem intended to treat various conditions of the hip joint, such as degeneration, fractures, and failures of previous hip surgeries, all of which aim to restore or improve physiological function.
No
Explanation: The device described is a femoral stem intended for implantation during hip replacement surgery. Its purpose is to treat various hip joint conditions, not to diagnose them.
No
The device description clearly states it is a femoral stem made from forged titanium alloy with a coating, indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy with coatings, designed to be surgically placed in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties and fatigue testing, which are relevant to the structural integrity of an implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace or support a damaged hip joint.
N/A
Intended Use / Indications for Use
The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are intended 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 osteoarthritis; patients with hips at risk of dislocation; femoral neck fracture or proximal fracture to hip joint.
The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.
Product codes
LZO, KWY, LWJ, MEH
Device Description
The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLUS Standard and Lateral Femoral Stems with TilHA cleared via K120211 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6AI-4V with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.
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
A review of the mechanical data indicates that the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure.
The following mechanical tests were used as a basis for the determination of substantial equivalence:
- Stem Fatigue Testing
- Neck Fatigue Testing
All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF -- 1762.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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We are smith&nephew
Nephew - POLARSTEM andard and Lateral Femoral Stems with Ti/HA
K130728 Paqe 1 of 2
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
OCT 1 0 20
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Date of Summary: | October 7, 2013 | | |
| Contact Person and Address: | Sameer Mansour, Regulatory Affairs Specialist
T (901) 399-5579
F (901) 566-7569 | | |
| Name of Device: | POLARSTEM Standard and Lateral Femoral Stems
with Ti/HA | | |
| Common Name:
Device Classification Name
and Reference: | Total Hip Joint, Femoral Component, Cementless
21 CFR 888.3353 - Hip joint metal/polymer/metal semi- | | |
| | constrained cemented or nonporous uncemented
prosthesis | | |
| | 21 CFR 888.3390 - Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis | | |
| | 21 CFR 888.3360 - Hip joint femoral (hemi-hip)
metallic cemented or uncemented prosthesis | | |
| Device Class: | Class II | | |
| Panel Code: | Orthopaedics/87 | | |
| Product Code: | LZO, KWY, LWJ, MEH | | |
Device Description
The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLUS Standard and Lateral Femoral Stems with TilHA cleared via K120211 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6AI-4V with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.
Intended Use
The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are intended 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 osteoarthritis; patients with hips at risk of dislocation; femoral neck fracture or proximal fracture to hip joint.
The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.
1
Technological Characteristics
A review of the mechanical data indicates that the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The overall design, materials, and indications for use for the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|----------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | SL-PLUS Standard and Lateral
Femoral Stems with Ti/HA | K120211 | 07/19/2012 |
| Smith & Nephew, Inc. | ANTHOLOGY Hip Stems | K052792 | 10/07/2005 |
| Landos, Inc. | CORAIL Hip Stems | K953111 | 12/27/1996 |
The following mechanical tests were used as a basis for the determination of substantial equivalence:
- Stem Fatigue Testing
- · · Neck Fatigue Testing
All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF -- 1762.
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed in the table above.
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an eagle or bird with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gb09 Silver Spring, MD 20993-0002
October 10, 2013
Smith & Nephew, Incorporated Mr. Sameer Mansour Regulatory Affairs Specialist 7135 Goodlett Farms Parkwav Cordova. Tennessee 38016
Re: K130728
Trade/Device Name: POLARSTEM Standard & Lateral Femoral Stems with TilHA 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, KWY, LWJ. MEII Dated: September 12, 2013 Received: September 13, 2013
Dear Mr. Mansour:
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 enacunent 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 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 - Mr. Sameer Mansour
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 I. Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
K130728 510(k) Number (if known):
Device Name: POLARSTEM Standard & Lateral Femoral Stems with TilHA
Indications for Use:
The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are 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 distocation
· Femoral neck fracture or proximal fracture to hip joint
The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.
AND/OR
Prescription x Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices