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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
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.
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement
- Femoral and Tibial bone voids
- Metaphyseal reconstruction
The Triathlon® Tritanium® Cone Augments are intended for cemented or cementless use.
Triathlon® Tritanium® Central Femoral Cone Augment:
The subject Triathlon® Tritanium® Central Femoral Cone Augment is an extension of the Triathlon® Total Knee System product line and is intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is composed of commercially pure titanium (raw material per ASTM F1580, processed material per ASTM F67).
The subject Triathlon® Tritanium® Central Femoral Cone Augment is designed to be used with the Triathlon® Total Stabilizer (TS) femoral components and is compatible with other Triathlon® Total Knee System components. The Triathlon® Tritanium® Central Femoral Cone Augments are intended to be cemented to the respective Triathlon® femoral components and are intended for fixation within the distal femur with or without bone cement. Triathlon® Tritanium® Central Femoral Cone Augments are intended to be used where there is a femoral metaphyseal defect secondary to trauma, failed previous prosthesis, or severe degeneration.
Triathlon® Femoral Distal Augment:
The subject Triathlon® Femoral Distal Augment is a modified version of the Triathlon® Femoral Distal Augment that is a component of the Triathlon® Total Knee System product line. It is intended to be used as an optional accessory component in primary or revision Total Knee Arthroplasty. It is a sterile, single-use device that is composed of either Cobalt-Chrome-Molybdenum (Co-Cr-Mo per ASTM F75) or Cobalt-Chrome (per ASTM F1537). These are the same materials as the predicate devices identified in this 510(k) premarket notification.
The subject Triathlon® Femoral Distal Augment is designed to be used with the Triathlon® TS or Triathlon® Posterior Stabilizer (PS) femoral components and is compatible with other Triathlon® Total Knee System components. The subject device is intended for attachment to the respective Triathlon® TS or PS femoral components with a locking screw; the augment-femoral component construct is intended to be cemented into the prepared distal femur. The Triathlon® Femoral Distal Augments are intended to be used in cases with severely inadequate medial or lateral femoral bone stock requiring additional fixation of the femoral components.
This is a medical device 510(k) premarket notification for knee joint replacement components, not an AI/ML device. Therefore, the requested information (acceptance criteria for an AI device, associated study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training, etc.) is not applicable to this document.
The document describes non-clinical testing performed for the orthopedic implants, such as:
- Characterization of chemistry, physical, and mechanical properties.
- Impaction test & morphology analysis.
- Micromotion analysis.
- Cantilever fatigue test.
- Torque test analysis.
- MRI analysis (to determine if the device created a new worst-case for image artifact, magnetically induced torque, displacement, or RF induced heating).
- Tolerance analysis.
- Fatigue strength analysis.
The document states that "Clinical testing was not required as a basis for substantial equivalence." This further indicates the absence of a study that would address the acceptance criteria relevant to an AI/ML device's performance.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.