(62 days)
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip implant system used for partial hip replacement (hemiarthroplasty) in patients with a non-functional femoral head due to femoral neck fracture, which is inherently a therapeutic intervention to restore function and alleviate symptoms.
No
This device is a prosthetic hip system intended to replace a diseased or broken femoral head and/or neck, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a hip implant system, which is a physical medical device, not software.
Based on the provided information, 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: The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is a physical implant designed to replace a damaged femoral head and/or neck in the hip joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for partial hip arthroplasty, a surgical procedure.
The device is a surgical implant, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.
Product codes
LZY, KWY
Device Description
The TANDEM Hip System is designed to be used for hemiarthroplasty as implantation of these devices replace diseased, affected, or broken femoral head and/or neck with a prosthetic component, while keeping the natural acetabulum, or hip socket, intact. The TANDEM Hip System includes the TANDEM Unipolar Hip System and TANDEM International Bipolar Hip Systems are used for partial hip replacement procedure, in which the unipolar shell are designed to articulate against the host acetabular articular cartilage and replace the femoral head and/or neck during the implantation procedure. The key difference between a unipolar and a bipolar version of the TANDEM Hip System is number of rotational points that are provided – single (unipolar) or two (bipolar) — within the socket.
The TANDEM Unipolar Hip System comprises of unipolar femoral head and taper sleeve. The TANDEM Unipolar femoral head components are manufactured using Cobalt-Chromium alloy conforming to ASTM F75 and ISO 5832-4. The Taper Sleeve components are manufactured from titanium (Ti644V) alloy conforming to ASTM F1472 and ISO 5832-3. The Taper Sleeve components are also manufactured from annealed ELI (extra low interstitial) grade Titanium alloy (Ti6Al4V) conforming to ASTM F136.
The TANDEM International Bipolar Hip System is manufactured from cobalt chrom cobalt chromium (CoCr) alloy conforming to ASTM F75 and ISO 5832-4, Ultra High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648 and ISO 5834-2, titanium (Ti6Al4V) alloy conforming to ASTM F1472 and ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
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)
The purpose of this traditional 510(k) is to request clearance from FDA for labeling changes to the subject Smith & Nephew TANDEM Hip System implants.
The subject Smith & Nephew TANDEM Hip System devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled.
Therefore, since there are no changes to the design features, materials, or manufacturing methods of the TANDEM Hip System devices, no performance testing (bench, animal, clinical) was required.
Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2023
Smith & Nephew, Inc. Nikita Deshpande Sr. Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K231448
Trade/Device Name: TANDEM Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: LZY, KWY Dated: May 18, 2023 Received: May 18, 2023
Dear Nikita Deshpande:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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-S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of JointArthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
TANDEM Hip System
Indications for Use (Describe)
The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.
The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| K231448 Page 1 of 3 | |||
|---|---|---|---|
| VI-\ C- LIGO 100 OUL | 0000 0- 11 |
21 CFR 807.92(a)(1)
| Applicant Name | Smith & Nephew, Inc. | |
|---|---|---|
| Applicant Address | 1450 Brooks Road Memphis TN 38116 United States | |
| Applicant Contact Telephone | 901-825-8527 | |
| Applicant Contact | Ms. Nikita Deshpande | |
| Applicant Contact Email | nikita.deshpande@smith-nephew.com | |
| 21 CFR 807.92(a)(2) | ||
| Device Trade Name | TANDEM Hip System | |
| Common Name | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis | |
| Classification Name | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | |
| Regulation Number | 888.3360 | |
| Product Code | LZY | |
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K896580 | TANDEM UNI-POLAR Hip System | LZY |
| K023743 | TANDEM International Bipolar Hip System | KWY |
| K211176 | Smith & Nephew Hip System | LPH |
| 21 CFR 807.92(a)(4) | ||
| The purpose of this traditional 510(k) is to notify FDA of Smith & Nephew's intent to request clearance for labeling updates to Smith & |
Nephew's TANDEM Hip System.
The TANDEM Hip Systems have been initially cleared by FDA and the information related to the clearance of these devices has been provided below:
- TANDEM Unipolar Hip System (CoCr Heads and Taper Sleeves) – K896580 (S.E Date – 02/15/1990) 2. TANDEM INTL (International) Bipolar Hip System – K023743 Letter To File (Date – 01/21/2004) Note: The TANDEM International Bipolar Hip System is a modified version of the TANDEM Bipolar System which was cleared for market under 510(k) submission number K023743.
The subject Smith & Nephew TANDEM Hip System devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled.
The labeling updates include changes made to the (IFU), device labels, and surgical technique. The indications for use and target patient population have been limited for using the subject TANDEM Hip System devices and post market surveillance data. These updates have been made to the European Medical Device Regulation
4
2017/745 and standardization of verbiage across Smith & Nephew's hip implants.
The TANDEM Hip System is designed to be used for hemiarthroplasty as implantation of these devices replace diseased, affected, or broken femoral head and/or neck with a prosthetic component, while keeping the natural acetabulum, or hip socket, intact. The TANDEM Hip System includes the TANDEM Unipolar Hip System and TANDEM International Bipolar Hip Systems are used for partial hip replacement procedure, in which the unipolar shell are designed to articulate against the host acetabular articular cartilage and replace the femoral head and/or neck during the implantation procedure. The key difference between a unipolar and a bipolar version of the TANDEM Hip System is number of rotational points that are provided – single (unipolar) or two (bipolar) — within the socket.
Materials
The TANDEM Unipolar Hip System comprises of unipolar femoral head and taper sleeve. The TANDEM Unipolar femoral head components are manufactured using Cobalt-Chromium alloy conforming to ASTM F75 and ISO 5832-4. The Taper Sleeve components are manufactured from titanium (Ti644V) alloy conforming to ASTM F1472 and ISO 5832-3. The Taper Sleeve components are also manufactured from annealed ELI (extra low interstitial) grade Titanium alloy (Ti6Al4V) conforming to ASTM F136.
The TANDEM International Bipolar Hip System is manufactured from cobalt chrom cobalt chromium (CoCr) alloy conforming to ASTM F75 and ISO 5832-4, Ultra High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648 and ISO 5834-2, titanium (Ti6Al4V) alloy conforming to ASTM F1472 and ISO 5832-3.
Intended Use/Indications for Use
The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral neck fracture.
The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.
Indications for Use Comparison
The purpose of this traditional 510(k) is to notify FDA of Smith & Nephew's intent to request clearance for labeling updates to Smith & Nephew's TANDEM Hip System. The labeling updates include changes to the indications for use.
The Smith & Nephew TANDEM Unipolar and International Bipolar Hip Systems are identical in function, materials, sterilization, manufacturing methods and operational principles to the commercially available predicate devices TANDEM Unipolar Hip System (K896580, 02/15/1990) and TANDEM International Bipolar Hip System (K0237343, 01/21/2004).
The labeling updates include changes made to the (IFU), device labels, and surgical technique. The indications for use and target patient population have been limited for using the subject TANDEM Hip System devices and post market surveillance data. These updates have been made to the European Medical Device Regulation 2017/745 and standardization of verbiage across Smith & Nephew's hip implants.
Technological Comparison
The devices that comprise the TANDEM Unipolar and Bipolar Hip System have the same technological characteristics, including device design and material, as the predicate devices previously cleared by the FDA. Therefore, no additional testing was performed for the subject devices to support the proposed labeling updates. There are no new issues related to safety and effectiveness of the subject devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The purpose of this traditional 510(k) is to request clearance from FDA for labeling changes to the subject Smith & Nephew TANDEM Hip System implants.
The subject Smith & Nephew TANDEM Hip System devices are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared. These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled.
Therefore, since there are no changes to the design features, materials, or manufacturing methods of the TANDEM Hip System devices, no performance testing (bench, animal, clinical) was required.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
5
Clinical data was not needed to support the safety and effectiveness of the subject devices.
No new or modified hip implant components are being introduced as a result of this filing. The subject devices are substantially equivalent to the previously 510(k) cleared predicate devices.