Search Results

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis

· Post-traumatic loss of knee joint configuration and function

• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques
• · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
• increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is intended for cemented use, single use only.

The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE (Ultra-High-Molecular-Weight-Polyethylene) or ECiMa (Vitamin E enriched advanced polyethylene) tibial tray with a titanium alloy keel extension and all-polyethylene (UHMWPE) patellar component for use in primary and revision total knee arthroplasty. The Unity Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).

• The CR femoral component is intended for use in conjunction with the CR tibial insert or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
• The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).

The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.

The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee MC Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The provided document is a 510(k) Premarket Notification from the FDA for the "Unity Total Knee System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on a clinical study proving device meets specific acceptance criteria in the way a de novo or PMA submission might.

However, it does outline the non-clinical tests performed to support substantial equivalence. While it doesn't present acceptance criteria and reported performance in a table with specific thresholds, it implies that the device met the requirements of the standards and analyses conducted.

Here's an attempt to structure the information based on your request, understanding that the scope of this document is a 510(k) and not a detailed clinical study report:

1. Table of Implied Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify sample sizes for mechanical testing. For example, for "Constraint determination," it doesn't state how many implants were tested.

• Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for the non-clinical tests mentioned.
• Data Provenance: Not explicitly stated (e.g., country of origin), but the tests are non-clinical (laboratory-based) and not human subject data. Retrospective/Prospective is not applicable to these types of non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these non-clinical tests is established by the accepted scientific and engineering principles codified in the referenced ASTM and ISO standards, and by established scientific methods, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data interpretation or image annotation, not for mechanical or material testing of devices. The "judgment" for these tests comes from adherence to the test standard and engineering analysis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a 510(k) clearance based on substantial equivalence, which often relies on non-clinical performance and comparison to predicate devices rather than direct human clinical trials for effectiveness in the same way a new drug or novel device might require.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (total knee system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM F1223-20, ISO 21536:2023, ASTM F2723-21). These standards define procedures and acceptable performance metrics.
• Engineering Principles and Benchmarking: Comparison to known performance characteristics of the legally marketed predicate devices, as well as established material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model or software algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons mentioned in point 8.

Ask a specific question about this device