# K132624: Triathlon Tritanium Metal-Backed Patella

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Nov 26, 2013 after 96 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933785 (1995). 16 ancestors in all.
38 later devices descend from it; 7 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) Summary page 1.
- K061521: Triathlon Metal Backed Patella, Howmedica Osteonics Corp. (2006) Summary page 1.
- K051146: Triathlon Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 1.
- K051977: Scorpio Knee System Tibial Inserts and Patellar Components, Howmedica Osteonics Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K211221: Porous Patella and Porous Tibia Baseplate (2021), 5 descendants of its own
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own

## Recalls of this device
- Mar 5, 2021 · Class II · Z-1379-2021: The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutti

## Indications for use
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' TritaniumO Tibial Baseplate and Tritaium' Metal-Backed Patella components are indicated for both uncernented and cemented use. The TriathionO Total Knee System beaded and beaded with Peri-Apatite components are Intended for uncemented use only. The TriathlonO All Polyethylene tiblal components are indicated far cemented use only. Additional indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: "Lgamentous 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 (7S) 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 sur gical procedure, accompanied by bane loss.

Source page: https://510kreport.com/device/K132624
Methodology: https://510kreport.com/methodology