(111 days)
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No
The document describes a mechanical implant (femoral stem) and its performance testing, with no mention of AI or ML technologies.
Yes
The device is a femoral stem (hip implant) used to treat advanced degeneration of the hip joint, fractures, or failed previous hip surgeries, which clearly indicates a therapeutic purpose.
No
The device description and intended use indicate that the POLARSTEM is an implant (femoral stem for hip replacement), not a device used to diagnose a medical condition. Its purpose is to treat conditions, not identify them.
No
The device description explicitly states it is a femoral stem made of titanium alloy with a coating, which is a physical implantable hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a femoral stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to treat conditions affecting the hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The POLARSTEM Collared and Valgus Stem with Ti/HA (INTEGRATION-PLUSY) 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
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, LWJ, MEH
Device Description
The POLARSTEM Collared (Standard and Lateral) and Valgus femoral stems designed for noncemented use are made of a titanium alloy (Ti-6Al-4V) with a fully porous titanium plasma/hydroxyapatite coating (Ti/HA). The design incorporates a highly polished neck area, distal grooves to increase rotational stability, and a 12/14 taper. The collared and valgus femoral stems are substantially equivalent to the POLARSTEM standard and lateral femoral stem with Ti/HA cleared via K130728.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint, femoral head
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were used as a basis for the determination of substantial equivalence:
- . Hip Stem Fatigue Testing
- . Range of Motion Analysis
A review of the mechanical data indicates that the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
Smith & Nephew, Incorporated Mr. Jeff Sprague Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K143739
Trade/Device Name: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA 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, MEH Dated: March 10, 2015 Received: March 11, 2015
Dear Mr. Sprague:
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. 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 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
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Page 2 - Mr. Jeff Sprague
(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 forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Smith & Nephew POLARSTEM Collared and Valgus Femoral Stem with Ti/HA
510(k) Number (if known): K143739
Device Name: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
Indications for Use:
The POLARSTEM Collared and Valgus Stem with Ti/HA (INTEGRATION-PLUSY) 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
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
X Prescription 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)
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510(k) Summary Smith & Nephew POLARSTEM Collared and Valgus Femoral Stem with Ti/HA
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | April 1, 2015 |
| Contact Person | Jeff Sprague, Regulatory Affairs
T (901) 399-5215 F (901) 721-2736 |
| Name of Device: | POLARSTEM Collared (Standard and Lateral)
and Valgus Femoral Stem with Ti/HA |
| Common Name: | Total Hip Joint, Femoral Component,
Cementless |
| Device Classification Name and Reference: | 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 Collared (Standard and Lateral) and Valgus femoral stems designed for noncemented use are made of a titanium alloy (Ti-6Al-4V) with a fully porous titanium plasma/hydroxyapatite coating (Ti/HA). The design incorporates a highly polished neck area, distal grooves to increase rotational stability, and a 12/14 taper. The collared and valgus femoral stems are substantially equivalent to the POLARSTEM standard and lateral femoral stem with Ti/HA cleared via K130728.
Intended Use
The POLARSTEM Collared (Standard and Lateral) and Valgus Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:
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- 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
The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.
The above indications are substantially equivalent to the indications cleared for the POLARSTEM standard and lateral femoral stem with Ti/HA (K130728). The only difference is the removal of the following bullet points as they are considered subsets of the more general indications seen above. Removal of the following points does not change the indications.
- All forms of osteoarthritis
- Patients with hips at risk of dislocation
- Femoral neck fracture or proximal fracture to hip joint
Technological Characteristics
A review of the mechanical data indicates that the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA is capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The overall design, materials, and indications for use for the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA are substantially equivalent to the following commercially available predicate devices. The Ti/HA coating on the POLARSTEM Collared and Valgus femoral stem is identical in composition, properties, and manufacturing location (Smith & Nephew AG) to the predicate below.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-----------------------------------|------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew
Orthopaedics AG | POLARSTEM Standard and Lateral Femoral
Stems with Ti/HA | K130728 | 10/10/2013 |
The following tests were used as a basis for the determination of substantial equivalence:
- . Hip Stem Fatigue Testing
- . Range of Motion Analysis
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 Amendment 1 and 2 and are not included in this 510(k).
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Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA coated by Smith & Nephew AG. Based on the similarities to the predicate component and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate device listed above.