# K200782: Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 13, 2020 after 48 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: none
- 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)
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005) Summary page 6.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 6.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 6.

## 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 Tibial Baseplate and Tritanium Metal-Backed Patella 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 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/K200782
Methodology: https://510kreport.com/methodology