(90 days)
The ZUK Unicompartmental Knee System is indicated for patients with:
-Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
-Previous tibial condyle or plateau fractures with loss of anatomy or function.
-Varus or valgus deformities.
-Revision of previous arthroplasty procedures.
-These devices are indicated for cemented use only.
-The ZUK Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Indications for JOURNEY Unicompartmental Knee Replacement: Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
· Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
- · Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and
- · Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.
Indications for JOURNEY Patello-Femoral Replacement:
· Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or patellar fracture: and
· Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
The Smith & Nephew patello-femoral implants are intended for implantation with bone cement.
Indications for Combined Unicompartmental and Patello-Femoral Replacement:
· Post-traumatic arthritis;
- · Degenerative arthritis: and
- · Failed osteotomies and unicompartmental replacement
These indications will be used for the combined unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions. Combined Unicompartmental and Patello-Femoral implants are intended for implantation with bone cement.
The purpose of this 510(k) is to notify the FDA of our intent to market previously cleared Smith & Nephew knee implants with previously cleared ZUK knee implants. Together with existing Smith & Nephew knee implants, these devices will be marketed under the trade name ZUK Select Knee System. The nature of this filing is to seek FDA clearance for these existing devices to be used in various combinations to create a bicompartmental knee replacement prosthesis. No new or modified knee implant components or new device specific instruments are being introduced to this filing.
This document is a 510(k) premarket notification for the ZUK Select Knee System. It states that the device comprises existing, previously cleared components from Smith & Nephew and Zimmer. The purpose of this 510(k) is to seek clearance for using these existing devices in various combinations to create a bicompartmental knee replacement prosthesis.
Based on the provided text, a formal study to prove the device meets specific acceptance criteria is not described, as the filing relies on the substantial equivalence of its components to previously cleared devices. Therefore, much of the requested information regarding study details, sample sizes, expert ground truth, etc., is not applicable or not available within this document.
However, I can extract information about the testing performed and the conclusion regarding safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
Based on the document, specific, quantitative acceptance criteria for this new combined system are not presented in a traditional performance study format. Instead, the approach is based on demonstrating substantial equivalence to predicate devices, supported by mechanical testing.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Mechanical Performance | "Additional mechanical testing, Contact Area Analysis, was conducted on the subject device(s) to support the use of the components in combination." "Based on the testing, there are no new issues related to the safety and effectiveness of the subject device(s)." |
| Clinical Performance | "Clinical data was not needed to support the safety and effectiveness of the subject device(s)." |
| Material/Design Equivalence | "The ZUK Select Knee System is identical in function, identical design features, intended use, indications for use, operational principles because the parts are the identical product components cleared in previous premarket notifications." This essentially serves as the primary "acceptance criterion" for this type of 510(k) submission. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable as a traditional clinical or performance study with human or biological samples was not conducted for the ZUK Select Knee System itself. The mechanical testing mentioned (Contact Area Analysis) would involve a sample of the device components, but the specific number is not provided.
- Data Provenance: Not applicable for a clinical study. The existing components are from manufacturers (Smith & Nephew, Zimmer) operating in the USA. The data referenced is from previously cleared 510(k) submissions to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth typically refers to clinical diagnostic accuracy or outcome, which was not assessed in a direct clinical study for this 510(k) filing. The "ground truth" for substantial equivalence is the prior FDA clearance of the individual components and the supporting mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as a clinical test set requiring adjudication was not utilized.
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 knee implant system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a knee implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) specifically, the "ground truth" for asserting safety and effectiveness lies in the prior FDA clearance of the individual components and mechanical testing (Contact Area Analysis) demonstrating that combining these components introduces no new safety/effectiveness concerns.
8. The sample size for the training set
- Not applicable. No training set for a machine learning model or a clinical training cohort was mentioned.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.