(30 days)
No
The document describes a mechanical knee implant component and its compatibility with existing systems. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is a knee component for total knee replacement, which is a medical procedure intended to treat conditions like arthritis and failed previous surgeries, thereby providing a therapeutic benefit to the patient.
No
The device is a knee implant (Cemented Tibia Baseplate no Taper with JRNY Lock) used for treating various forms of arthritis and failed knee replacements. It is an orthopedic prosthetic device, not a diagnostic tool.
No
The device description clearly states it is a "Cemented Tibia Baseplate no Taper with JRNY Lock," which is a physical implant made of Ti-6Al-4V. This is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a component for total knee replacement surgery to address various forms of arthritis and failed previous surgeries. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical components of a knee implant (tibia baseplate, locking mechanism, stem, fins) made of Ti-6Al-4V. This is consistent with a medical device intended for implantation, not for in vitro diagnostic testing.
- Lack of IVD Keywords: The text does not mention any terms related to in vitro diagnostics, such as:
- Samples (blood, urine, tissue, etc.)
- Assays or tests
- Reagents
- Analyzing biological markers
- Diagnosis based on laboratory results
- Performance Studies: The performance studies mentioned are mechanical testing (Component Interlock Strength) and bacterial endotoxin testing, which are relevant for implantable devices, not IVDs.
In summary, the device described is a surgical implant used in total knee replacement procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Total Knee components are indicated for:
· Rheumatoid arthritis
· Post-traumatic arthritis, osteoarthritis, or degenerative arthritis
· Failed osteotomies, unicompartmental replacement, or total knee replacement.
· Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact
The Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The subject devices of this Special 510(k) are the Cemented Tibia Baseplate no Taper with JRNY Lock. The subject Cemented Tibia Baseplate no Taper with JRNY Lock are tibia baseplate components, and a line extension of the ANTHEM Tibia Baseplate cleared under premarket notification K142807 (S.E. 12/22/2014). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism for the JOURNEY II BCS Knee System, cleared under premarket notifications K111711 (S.E. 09/16/2011).
The subject Cemented Tibia Baseplate no Taper with JRNY Lock is designed to be implanted with the use of bone cement and is made of Ti-6Al-4V. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's JOURNEY Nonporous Tibia Baseplate, originally cleared under premarket notification K042515 (S.E. 03/14/2005) and updated under the JOURNEY II BCS Knee System premarket notifications K111711 (S.E. 09/16/2011) respectively. The distal side of the implant has a central stem and two large posterior-directed fins. The subject device includes the same stem length for all sizes, though the fin sizes vary between baseplate sizes. The distal side of the implant has an identical design to Smith & Nephew's ANTHEM Tibia Baseplate, cleared under premarket notification K142807 (S.E. 12/22/2014). The subject Cemented Tibia Baseplate no Taper with JRNY Lock includes multiple sizes in both left and right versions.
The subject inserts of the system, compatible with the subject Cemented Tibia Baseplate no Taper with JRNY Lock, have been previously cleared via premarket notification K220896 (S.E. 04/26/2022) to include the JOURNEY II Locking Mechanism. The articulating surface of the subject inserts have remained identical to the primary predicate system, ANTHEM PS Total Knee System cleared via premarket notification K142807 (S.E. 12/22/2014). Therefore, the existing femoral components cleared for the system via premarket notification K142807 (S.E. 12/22/2014) continue to be compatible and remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
A review of the leveraged mechanical data indicates that the subject Cemented Tibia Baseplate no Taper with JRNY Lock devices are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The Component Interlock Strength testing for the JOURNEY II Locking Mechanism from the JOURNEY II BCS Knee System premarket notification K111711 (S.E. 09/16/2022) was reviewed to determine the substantial equivalence.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72 (FDA Recognition Number 14-541).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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March 30, 2023
Smith & Nephew, Inc. Madison Padgett Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K230555
Trade/Device Name: Cemented Tibia Baseplate no Taper with JRNY Lock Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 27, 2023 Received: February 28, 2023
Dear Madison Padgett:
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.
1
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 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 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 Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K230555
Device Name
Cemented Tibia Baseplate no Taper with JRNY Lock
Indications for Use (Describe)
Total Knee components are indicated for:
· Rheumatoid arthritis
- · Post-traumatic arthritis, osteoarthritis, or degenerative arthritis
- · Failed osteotomies, unicompartmental replacement, or total knee replacement.
· Posterior stabilized knee systems are designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact
The Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.
| 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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3
510(k) Summary Smith & Nephew – Cemented Tibia Baseplate no Taper with JRNY Lock
| 510(k) Summary Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 30, 2023 |
| Primary Contact Person: | Madison Padgett, Regulatory Affairs Specialist II
Phone: (901) 456-8789 |
| Secondary Contact Person | Rose Beifuss, Senior Manager, Regulatory Affairs
Phone: (385) 253-2551 |
| Name of Device:
Common Name: | Cemented Tibia Baseplate no Taper with JRNY Lock
Cemented Tibial Baseplate Components |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH - Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prothesis |
| Predicate Device: | Primary Predicate - K142807 - ANTHEM PS Total
Knee System (S.E. 12/22/2014)
JWH
Secondary Predicate - K111711 - JOURNEY II BCS
Knee System (S.E. 09/16/2011)
JWH |
5 - 1
4
510(k) Summary Smith & Nephew - Cemented Tibia Baseplate no Taper with JRNY Lock
Device Description
The subject devices of this Special 510(k) are the Cemented Tibia Baseplate no Taper with JRNY Lock. The subject Cemented Tibia Baseplate no Taper with JRNY Lock are tibia baseplate components, and a line extension of the ANTHEM Tibia Baseplate cleared under premarket notification K142807 (S.E. 12/22/2014). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism for the JOURNEY II BCS Knee System, cleared under premarket notifications K111711 (S.E. 09/16/2011).
The subject Cemented Tibia Baseplate no Taper with JRNY Lock is designed to be implanted with the use of bone cement and is made of Ti-6Al-4V. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's JOURNEY Nonporous Tibia Baseplate, originally cleared under premarket notification K042515 (S.E. 03/14/2005) and updated under the JOURNEY II BCS Knee System premarket notifications K111711 (S.E. 09/16/2011) respectively. The distal side of the implant has a central stem and two large posterior-directed fins. The subject device includes the same stem length for all sizes, though the fin sizes vary between baseplate sizes. The distal side of the implant has an identical design to Smith & Nephew's ANTHEM Tibia Baseplate, cleared under premarket notification K142807 (S.E. 12/22/2014). The subject Cemented Tibia Baseplate no Taper with JRNY Lock includes multiple sizes in both left and right versions.
The subject inserts of the system, compatible with the subject Cemented Tibia Baseplate no Taper with JRNY Lock, have been previously cleared via premarket notification K220896 (S.E. 04/26/2022) to include the JOURNEY II Locking Mechanism. The articulating surface of the subject inserts have remained identical to the primary predicate system, ANTHEM PS Total Knee System cleared via premarket notification K142807 (S.E. 12/22/2014). Therefore, the existing femoral components cleared for the system via premarket notification K142807 (S.E. 12/22/2014) continue to be compatible and remain unchanged.
5
510(k) Summary Smith & Nephew - Cemented Tibia Baseplate no Taper with JRNY Lock
Indication for Use:
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are intended for use with cement only and are single use devices.
Technological Characteristics
The subject devices were modified by incorporating the identical locking mechanism cleared under the JOURNEY II BCS Knee System premarket notification K111711 (S.E. 09/16/2011) to the primary predicate ANTHEM Tibia Baseplate cleared under K142807 (S.E. 12/22/2014). A review of the technological characteristics indicates that the subject Cemented Tibia Baseplate no Taper with JRNY Lock are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The subject devices are substantially equivalent to the predicate devices listed in the following table in function, intended use, indications for use, design, and material composition.
| Manufacturer | Submission Name | Submission
Number | Clearance
Date |
|----------------------|-----------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | ANTHEM PS Total Knee System | K142807 | 12/22/2014 |
| Smith & Nephew, Inc. | JOURNEY BCS Knee System | K111711 | 09/16/2011 |
Table 5.1: Substantially Equivalent Predicates
6
510(k) Summary Smith & Nephew - Cemented Tibia Baseplate no Taper with JRNY Lock
Performance Testing:
A review of the leveraged mechanical data indicates that the subject Cemented Tibia Baseplate no Taper with JRNY Lock devices are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The Component Interlock Strength testing for the JOURNEY II Locking Mechanism from the JOURNEY II BCS Knee System premarket notification K111711 (S.E. 09/16/2022) was reviewed to determine the substantial equivalence.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72 (FDA Recognition Number 14-541).
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Cemented Tibia Baseplate no Taper with JRNY Lock. Based on the similarities to the predicate devices and rationale to support substantial equivalence, the subject devices are substantially equivalent to the commercially available predicate devices listed in Table 5.1.