# K123486: Triathlon Tritanium Tibial Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: May 3, 2013 after 171 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933785 (1995). 12 ancestors in all.
51 later devices descend from it; 9 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K072160: Nexgen Trabecular Metal Tibial Tray, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K132624: Triathlon Tritanium Metal-Backed Patella (2013), 38 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own

## Recalls of this device
- May 19, 2026 · Class II · Z-2462-2026: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate
- May 19, 2026 · Class II · Z-2461-2026: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate
- Mar 30, 2022 · Class II · Z-1237-2022: Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
- Feb 10, 2021 · Class II · Z-1186-2021: Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there m
- Jun 23, 2016 · Class II · Z-2390-2016: It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. 
- Sep 29, 2015 · Class II · Z-0249-2016: Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
- Feb 12, 2015 · Class II · Z-1283-2015: Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

## Indications for use
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), 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 Stabilizing (PS) 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 The Triathlon® Tritanium® Tibial Baseplates are indicated for both cemented and uncemented use.

Source page: https://510kreport.com/device/K123486
Methodology: https://510kreport.com/methodology