# K061521: Triathlon Metal Backed Patella

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 11, 2006 after 70 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: 1 generation back to K032418 (2003). 1 ancestor in all.
43 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032418: Duracon Total Knee System with Peri-Apatite Coating, Howmedica Osteonics Corp. (2003) Summary page 2.

## 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

## Indications for use
The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: * Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; * Rheumatoid arthritis; * Correction of functional deformity; * Revision procedures where other treatments or devices have failed; * Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, * Irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement.

Source page: https://510kreport.com/device/K061521
Methodology: https://510kreport.com/methodology