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K Number
K152494
Device Name
Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
Manufacturer
ZIMMER, INC.
Date Cleared
2015-11-25

(85 days)

Product Code
JWH,KRO
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K946150,K013385
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For NexGen Augments used with NexGen Knee Systems - Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): This device is indicated for patients with severe knee pain and disability due to:

  • Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

  • Collagen disorders, and/or avascular necrosis of the femoral condyle.

  • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

  • Moderate valgus, varus, or flexion deformities.

  • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

· CR and LPS porous coated femoral and tibial baseplate components may be used cemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

· NexGen Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

For NexGen Augments used with NexGen Rotating Hinge Knee System:

This device is indicated for patients with:

  • Moderate to severe knee instability.

  • Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.

  • Valgus, varus, or flexion deformities.

  • The salvage of previously failed surgical attempts.
    This device is intended for cemented use only.

Device Description

The NexGen augments are used with the following NexGen Knee Systems: NexGen Rotating Hinge Knee, NexGen Complete Knee Solution: Cruciate Retaining Augmentable (CRA), Legacy Constrained Condylar (LCCK), Cruciate Retaining (CR), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS). This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) premarket notification for Zimmer NexGen Knee Solution Tibial and Femoral Augments does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as typically seen for AI/ML-driven medical devices.

The document is a clearance letter and a 510(k) summary for a physical medical device (knee implants - augments), not a software or AI/ML device. Therefore, it discusses performance based on non-clinical testing (shelf life, attachment strength, PMMA coated titanium substrate to bone cement properties) and states that clinical data and conclusions were were not needed for this device's clearance.

The questions you've asked (regarding acceptance criteria for device performance in terms of AI metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are specifically relevant to the evaluation of AI/ML software as a medical device (SaMD) or AI-assisted devices. This document does not describe such an evaluation.

§ 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.