(142 days)
The Triathlon TS Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All total knee components presented in this submission are provided sterile for single-use.
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid 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 and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
- . Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee joint. .
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament ● integrity or function.
Indications for Bone Augments: - . Painful, disabling joint disease of the knee secondary to: degenerative arthritis. rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical . procedure, accompanied by bone loss.
The Triathlon TS Total Knee System components are intended for cemented use only.
A total stabilizing version of the Triathlon Total Knee System has been developed and will now include femoral components and tibial inserts compatible with the Triathlon universal tibial components cleared previously. The new Triathlon TS Knee is designed to accommodate patients with severely deficient bone stock who require additional components for increased stabilization. The Triathlon TS System will include femoral components, stem extenders, offset adapters, stems, and tibial inserts in standard and TS Plus design. Implants will be available in sizes 1 through 8. Product descriptions, product codes and engineering drawings are provided for review.
This document describes the Triathlon® TS Knee System, a total knee joint replacement prosthesis. However, the provided text does not contain information regarding objective acceptance criteria or a study that specifically proves the device meets such criteria.
The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a de novo clinical study with predefined acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this submission.
Here's a breakdown based on the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable / Not Provided. The 510(k) summary does not include an objective performance study with specific acceptance criteria that the Triathlon® TS Knee System was evaluated against. Instead, it relies on demonstrating substantial equivalence to predicate devices based on similarities in design, materials, and intended use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided. No "test set" in the context of a performance study is mentioned. The submission relies on establishing substantial equivalence to existing, legally marketed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable / Not Provided. Since no formal performance study with a test set requiring ground truth establishment is described, this information is not present.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. No adjudication method is mentioned as there is no described test set requiring one.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on design and indications for use, not comparative effectiveness with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / No. This device is a physical knee prosthesis, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. As no formal study with a "ground truth" is described, this information is absent. The basis for safety and effectiveness is substantial equivalence to predicates.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided. This device is a physical implant, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Not Provided. (Refer to point 8).
Summary of what the K070095 document does provide:
- Device Description: A total stabilizing version of the Triathlon Total Knee System, including femoral components, tibial inserts, stem extenders, offset adapters, and stems.
- Intended Use and Indications for Use: Clearly states the purpose of the device for primary and revision total knee arthroplasty, and specific conditions for its use, including ligamentous instability and severe bone loss.
- Substantial Equivalence: The primary method of demonstrating safety and effectiveness is through comparison to existing predicate devices:
- Regulatory Clearance: The FDA letter confirms the review and determination of substantial equivalence, allowing the device to be marketed.
In essence, this 510(k) submission relies on the regulatory pathway of substantial equivalence, where a new device is deemed as safe and effective as an already legally marketed predicate device, rather than requiring a new, de novo clinical trial with explicit acceptance criteria and performance study data.
§ 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.