(45 days)
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 standard fracture -management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented 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 TS Cone Augments are intended for cemented or cementless use.
The subject Triathlon Intermediate Tibial Inserts will be available in the following configurations:
- Cruciate Retaining (CR) intermediate thicknesses of inserts (10mm, 12m, 14mm) will . be added to the previously cleared size range of 9mm, 13mm, 16mm and 19mm
- Cruciate Substituting (CS) intermediate thicknesses of inserts (10mm, 12mm and ● 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm
- Posterior Stabilizing (PS) intermediate thicknesses of inserts (10mm. 12mm and . 14mm) will be added to the previously cleared size range of 9mm, 11mm, 13mm, 16mm, 19mm, 22mm and 25mm
The design of these inserts are identical to the predicate devices in terms of condylar geometry. post dimensions (in PS design) and locking wire feature. The inserts will be available in X3 ETO, and N2Vac styles.
Additionally. MR Conditional labeling is being added for the subject intermediate thickness inserts as well as those X3 ETO tibial inserts and patellar components previously cleared in premarket notification K172634.
This document is a 510(k) premarket notification from the FDA for the Triathlon Total Knee System. It is a regulatory approval and not a detailed study report with acceptance criteria and performance metrics typically seen in AI/ML device submissions. Therefore, many of the requested fields cannot be filled.
However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves as a form of acceptance criteria and evidence of performance for this type of medical device.
Acceptance Criteria and Study for Triathlon Total Knee System (K173849)
This submission is for a Traditional 510(k) for an orthopedic implant (knee replacement system), not an AI/ML diagnostic device. As such, the concept of "acceptance criteria" and "device performance" relies on demonstrating substantial equivalence to already legally marketed devices through material characterization, mechanical testing, and biocompatibility, rather than evaluating diagnostic accuracy or clinical outcomes as would be done for AI/ML.
The "study" here refers to the non-clinical testing conducted to support the substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are generally compliance with recognized standards and demonstration that new designs do not create a "new worst case" compared to predicate devices. "Reported device performance" is the manufacturer's conclusion that these criteria are met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: Compliance with ASTM F648, ASTM F2565 and FDA Guidance for UHMWPE. | Material characterization previously presented for predicate devices is unchanged and supports substantial equivalence. |
| Biocompatibility: Compliance with EN ISO 10993-1:2010 and FDA Guidance. | Biocompatibility testing performed for predicate devices is representative. |
| Sterilization Efficacy: Compliance with EN ISO 11135:2014 for Ethylene Oxide Sterilization Validation. | Ethylene Oxide Sterilization Validation performed for predicate devices is representative. |
| Wear Resistance: Testing based on ISO/DIS 14243-3:2014. | Wear test performed for predicate devices is representative, as new thicknesses do not create a new worst case. |
| Static Shear Insert Baseplate Locking Mechanism: Demonstrates integrity of the locking mechanism. | Static Shear Insert Baseplate Locking Mechanism Test performed for predicate devices is representative, as new thicknesses do not create a new worst case. |
| Fatigue Strength (Single Axis & Multi-Axis): Demonstrates durability under cyclic loading. | Single Axis Fatigue Test and Multi-Axis Fatigue Test performed for predicate devices are representative, as new thicknesses do not create a new worst case. |
| MR Conditional: Compliance for image artifact, magnetically induced torque/displacement, and RF induced heating per ASTM F2052-15, F2213-06, F2119-07, F2182-11a. | New intermediate thicknesses, as well as previously cleared X3 ETO tibial inserts and patellar components, do not create a new worst case compared to previously cleared Triathlon Total Knee components (K172326). Devices are considered MR Conditional. |
| Pyrogenicity: Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011 to achieve endotoxin limit |
§ 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.