(61 days)
No
The device description and performance studies focus on a reusable surgical tool for preparing the femur for a hip implant, with no mention of AI or ML technologies.
No
The device is described as a reusable tool used to prepare the bony bed of the proximal femur for the implantation of a hip implant, not the implant itself or a device that directly treats a condition. It is an accessory for a surgical procedure.
No
Explanation: The device is a surgical tool used to prepare the bony bed of the proximal femur for hip implant implantation, not to diagnose a condition.
No
The device description clearly states it is a "reusable tool" used to prepare the bony bed for a hip implant, and performance studies involved "cadaver/Sawbone surgery," indicating a physical, non-software device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a surgical tool used to prepare the bone during a hip replacement surgery. It is used in vivo (within the body) during the surgical procedure, not in vitro (outside the body) for analyzing specimens.
- Intended Use: The intended use clearly states it's for preparing the bony bed for a femoral stem implant, which is a surgical procedure.
- Device Description: The description confirms it's a reusable tool used with hip implants to prepare the bone.
The device is a surgical instrument, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The POLARSTEM™ 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.
The POLARSTEMTM 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 Subject Device is a reusable tool intended to be used with the hip implant POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™ Valgus Femoral Stem with Ti/HA. The Subject Device is used to prepare the bony bed of the proximal femur to allow implantation of the implant POLARSTEM™ in the femoral bone. The Subject Device is designed to be clipped onto the trial rasp to guide the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™ and to define the physical stop of the calcar reamer or planer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur, femoral bone
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
Functional testing was conducted on the Subject Device to evaluate its performance. The principal test method used was cadaver/Sawbone surgery to evaluate the Subject Device's usability, safety, and effectiveness with regard to the associated implants, reference materials and combinable medical devices. Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2021
Smith & Nephew, Inc. Pamela Hopkins Regulatory Affairs Specialist II 1450 East Brooks Rd Memphis, Tennessee 38116
Re: K211548
Trade/Device Name: POLARSTEM Calcar Reamer Guide 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: May 17, 2021 Received: May 19, 2021
Dear Pamela Hopkins:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun, PhD 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
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Indications for Use
510(k) Number (if known) K211548
Device Name POLARSTEM™ Calcar Reamer Guide
Indications for Use (Describe)
The POLARSTEMTM 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.
The POLARSTEMIM with Ti/HA is intended for single use only and is to be implanted without bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitted by: | Smith & Nephew, Inc.
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Revision Date: | July 16, 2021 |
| Contact Person: | Pamela Hopkins, Regulatory Affairs Specialist II
T (901) 399-5471
M (901) 427-7303 |
| Name of Device: | POLARSTEM™ Calcar Reamer Guide, an accessory tool that
is part of the POLARSTEM™ Collared (Standard and Lateral)
and POLARSTEM™ Valgus Femoral Stem with Ti/HA. |
| Common Name: | Total Hip Joint, Femoral Component |
| Device Classification Name and
Reference: | 21 CFR 888.3353 - Hip Joint Metal/Ceramic/Polymer 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 |
| Predicate Device: | POLARSTEM™ Calcar Reamer Guide, an accessory tool
included in K143739 which cleared the POLARSTEM™
Collared (Standard and Lateral) and POLARSTEM™
Valgus Femoral Stem with Ti/HA system |
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Device Description
The Subject Device is a reusable tool intended to be used with the hip implant POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™ Valgus Femoral Stem with Ti/HA. The Subject Device is used to prepare the bony bed of the proximal femur to allow implantation of the implant POLARSTEM™ in the femoral bone. The Subject Device is designed to be clipped onto the trial rasp to guide the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™ and to define the physical stop of the calcar reamer or planer.
Indications for Use
The POLARSTEM™ 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.
The POLARSTEM™ with Ti/HA is intended for single use only and is to be implanted without bone cement.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the Subject Device is substantially equivalent to the Predicate Device with regards to indications for use, material, and performance characteristics.
When compared to the Predicate Device, the Subject Device is nearly identical to the predicate instrument, with the exception of the distance between the hook and the rasp. The Subject Device has an improved hook design to reduce the risk of interference of material (bone debris) by adding additional clearance between the hook and the rasp.
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Substantial Equivalence Information
The materials and indications for use for the Subject Device are identical to the Predicate Device. The minor design difference between the Subject Device and the Predicate Device (i.e. the distance between the hook and the rasp) do not raise any new or different questions of safety and effectiveness. Therefore, the Subject Device is substantially equivalent to the Predicate Device.
Performance Testing
To further support a determination of substantial equivalence, functional testing was conducted on the Subject Device to evaluate its performance. The principal test method used was cadaver/Sawbone surgery to evaluate the Subject Device's usability, safety, and effectiveness with regard to the associated implants, reference materials and combinable medical devices. Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device.
Conclusion
The subject Calcar Reamer Guide is identical in function, intended use, and materials to the Predicate Device. The minor design difference between the Subject Device and the Predicate Device do not raise any new or different questions of safety and effectiveness. Therefore, the subject Calcar Reamer Guide is substantially equivalent to the legally marketed Predicate Device.