· 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.

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.

AI/ML Overview

This document is a 510(k) summary for a medical device (Cemented Tibia Baseplate no Taper with JRNY Lock), seeking substantial equivalence to predicate devices, not a study performing extensive clinical testing with detailed acceptance criteria and performance data as would be provided for a new, novel AI/ML device. Therefore, much of the requested information regarding acceptance criteria, study design (sample size, experts, ground truth, MRMC), and training sets for AI models is not applicable to this type of submission.

This submission primarily relies on mechanical performance data and comparisons to existing, cleared predicate devices. The conclusion explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

However, I can extract the relevant information where available and explain why other sections are not applicable.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance (Not Applicable in the context of an AI/ML device)

This document is for a medical device (a knee implant component), not an AI/ML device. Therefore, the concept of "acceptance criteria" and "device performance" as it pertains to statistical measures like sensitivity, specificity, accuracy, or reader improvement, does not apply in the same way.

The "acceptance criteria" here are based on the substantial equivalence to predicate devices through design similarity, material composition, and demonstration of equivalent mechanical performance (via leveraged data).

The "reported device performance" is essentially the successful demonstration that its mechanical performance (specifically the locking mechanism) is equivalent to or better than previously cleared devices and that it meets endotoxin limits.

Table of Acceptance Criteria and Reported Device Performance (as applicable to a physical device):

Acceptance Criteria Category	Specific Criterion/Test	Reported Device Performance
Mechanical Performance	Component Interlock Strength Testing	Leveraged data from K111711 (JOURNEY II BCS Knee System) was reviewed and deemed sufficient to demonstrate substantial equivalence. No new issues were identified regarding safety and effectiveness.
Biocompatibility/Sterility	Bacterial Endotoxin Testing	Completed and met acceptable endotoxin limits per FDA guidance and ANSI/AAMI ST72.
Substantial Equivalence	Design, Material, Function, Intended Use, Indications for Use	Found substantially equivalent to K142807 (ANTHEM PS Total Knee System) and K111711 (JOURNEY II BCS Knee System). No new issues related to safety/effectiveness.

Study Details (Not Applicable for most AI/ML questions)

2. Sample size used for the test set and the data provenance:

Not applicable for clinical data. The submission states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
For mechanical testing, the "sample size" would refer to the number of physical devices or components tested. This specific number is not provided, but the statement "A review of the leveraged mechanical data" implies that existing or previously generated test data from the predicate devices (K111711) was utilized. The provenance would be from laboratory mechanical testing of these devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission does not involve human expert interpretation of data to establish ground truth in the way an AI/ML device would (e.g., radiologists reviewing images). The ground truth for mechanical testing is established by engineering standards and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No human adjudication process as implied by this question. Mechanical testing results are objectively measured.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Mechanical ground truth: Established through engineering specifications, validated test methods (e.g., force, displacement measurements), and compliance with relevant standards (e.g., ISO, ASTM for medical device mechanical testing).
Biocompatibility ground truth: Established through laboratory testing for endotoxin levels compared to pre-defined acceptable limits in regulatory guidance (FDA Guidance, ANSI/AAMI ST72).

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this physical medical device submission.

9. How the ground truth for the training set was established:

Not applicable.

In summary: This 510(k) submission for a knee implant component primarily leverages existing data from predicate devices and mechanical testing to demonstrate substantial equivalence, rather than conducting a clinical study with human readers/interpreters or training an AI/ML model. Therefore, many of the questions asked, which are highly pertinent to AI/ML device submissions, are not applicable here.

Summary

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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.

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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

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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.

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)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Smith & Nephew – Cemented Tibia Baseplate no Taper with JRNY Lock

510(k) Summary Submitted by:	Smith & Nephew, Inc.Orthopaedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	March 30, 2023
Primary Contact Person:	Madison Padgett, Regulatory Affairs Specialist IIPhone: (901) 456-8789
Secondary Contact Person	Rose Beifuss, Senior Manager, Regulatory AffairsPhone: (385) 253-2551
Name of Device:Common Name:	Cemented Tibia Baseplate no Taper with JRNY LockCemented Tibial Baseplate Components
Device Classification Name andReference:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH - Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprothesis
Predicate Device:	Primary Predicate - K142807 - ANTHEM PS TotalKnee System (S.E. 12/22/2014)JWHSecondary Predicate - K111711 - JOURNEY II BCSKnee System (S.E. 09/16/2011)JWH

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510(k) Summary Smith & Nephew - Cemented Tibia Baseplate no Taper with JRNY Lock

Device Description

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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	SubmissionNumber	ClearanceDate
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

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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.

Regulation Number and Section

§ 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.