Triathlon® PKR X3® Tibial Inserts are components of the Triathlon® PKR System that is indicated for:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS™ Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- Lateral unicondylar
- Patellofemoral
- Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
The subject Triathlon PKR X3® Tibial Inserts and Mako X3® Uni Onlay Tibial Inserts are identical in design to their currently marketed predicates. The subject inserts will use a different method of terminal sterilization of ethylene oxide per ISO 11135 and will be formed by consolidating GUR1020 resin via conventional methods which meet the specifications of ASTM F648. The device sterilization method is identical to that used for the reference Triathlon X3 Tibial Inserts and Patellar Components.
This FDA 510(k) summary (K180612) describes a premarket notification for new versions of tibial inserts for knee replacement systems. Crucially, the document explicitly states that "Clinical Testing was not required as a basis for substantial equivalence." This means that the device's acceptance criteria and proof of meeting them are not based on clinical performance data (e.g., patient outcomes, diagnostic accuracy of an AI). Instead, the substantial equivalence determination relies on comparisons to legally marketed predicate devices through non-clinical testing.
Therefore, many of the questions you asked, which are relevant to clinical studies (especially those involving AI or human readers), cannot be answered from this document.
Here's an analysis based on the provided text, addressing what can be inferred and explaining why other information is not present:
Device Acceptance Criteria and Performance (Based on Non-Clinical Testing)
Since clinical testing was not required, the acceptance criteria are based on mechanical and material properties, sterilization efficacy, and biocompatibility, demonstrating that the new devices are equivalent to established predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Testing) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Material Properties | Conform to ASTM F648 for UHMWPE. | New device uses GUR1020 resin consolidated via conventional methods, meeting ASTM F648 specifications. |
| Biocompatibility | Meet EN ISO 10993-1:2010 and FDA Guidance. | Biocompatibility testing per EN ISO 10993-1:2010. |
| Sterilization Efficacy | Meet EN ISO 11135:2014 for Ethylene Oxide (EtO) sterilization. | Ethylene Oxide Sterilization Validation per EN ISO 11135:2014. |
| Pyrogenicity | Bacterial endotoxin limit |
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.