(103 days)
General Total Knee Arthroplasty (TKA) 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.
Triathlon Tritanium Tibial Baseplate:
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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 General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint
- Absent or non-functioning posterior cruciate ligament
- Severe anteroposterior instability of the knee joint
The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.
Triathlon Low Profile Tibial Tray:
The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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.
Triathlon Metal Backed Patellar:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis:
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
The devices covered by this submission include femoral components, tibial baseplates, tibial inserts, all-polyethylene tibial components, patellar components, metal backed patellar components, tibial and femoral augments, stems, stem extenders and offset adaptors used in total knee arthroplasty procedures. All devices have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The Triathlon Knee system components are manufactured from the following materials Cobalt Chromium Alloy, Titanium Alloy, Commercially Pure Titanium, Ultra-High Molecular Weight Polyethylene and Calcium Phosphate.
The purpose of this submission is to modify the labeling of the Triathlon Knee System to revise the contraindications.
This submission (K141056) details a labeling modification for the Triathlon Knee System, which includes various components like femoral components, tibial baseplates, tibial inserts, patellar components, etc. The document explicitly states that "Performance testing was not required in support of this submission because this submission covers a labeling modification to the contraindications. Clinical testing was not required as a basis for substantial equivalence."
Therefore, the provided document does not contain information about acceptance criteria or a study proving the device meets particular performance thresholds, beyond the legal requirement of substantial equivalence to predicate devices, for which no new performance data was presented in this submission.
Thus, I cannot populate the requested tables and information based on the given text. The relevant sections in the document explicitly state that no new performance or clinical testing was conducted or required for this particular submission.
§ 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.