# K190991: Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
- Decided: Aug 15, 2019 after 122 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943462 (1994). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143393: Triathlon Tritanium Cone Augments, Stryker Orthopaedics (2015) Summary page 5.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 5.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 5.

## Recalls of this device
- Aug 19, 2019 · Class II · Z-2758-2019: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- Aug 19, 2019 · Class II · Z-2757-2019: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- Aug 19, 2019 · Class II · Z-2760-2019: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- Aug 19, 2019 · Class II · Z-2759-2019: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

## 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® 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. Additional Indications for Cone Augments: • Severe degeneration or trauma requiring extensive resection and replacement • Femoral and Tibial bone voids • Metaphyseal reconstruction The Triathlon Tritanium® Cone Augment components are intended for cemented or cementless use.

Source page: https://510kreport.com/device/K190991
Methodology: https://510kreport.com/methodology