# K070095: Triathlon TS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 1, 2007 after 142 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031729 (2003). 4 ancestors in all.
64 later devices descend from it; 8 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973164: Howmedica Total Stabilizer Knee Components, Howmedica Corp. (1997) Summary page 2.
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 2.
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component, Howmedica Osteonics Corp. (2005) Summary page 2.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 2.

## Most influential descendants
- K072221: Modification to Triathlon TS Knee System (2007), 35 descendants of its own
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P (2013), 33 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own

## Recalls of this device
- Aug 15, 2014 · Class II · Z-1635-2015: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.
- Mar 25, 2013 · Class II · Z-1370-2013: Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femor
- Dec 10, 2009 · Not classified · Z-0759-2010: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Dec 10, 2009 · Not classified · Z-0760-2010: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Dec 10, 2009 · Not classified · Z-0761-2010: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Dec 10, 2009 · Not classified · Z-0757-2010: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Dec 10, 2009 · Not classified · Z-0758-2010: Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Apr 16, 2009 · Not classified · Z-1607-2009: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
- Apr 16, 2009 · Not classified · Z-1608-2009: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
- Apr 16, 2009 · Not classified · Z-1609-2009: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
- Apr 16, 2009 · Not classified · Z-1610-2009: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
- Nov 13, 2008 · Not classified · Z-0890-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
- Jul 31, 2007 · Not classified · Z-1231-2007: Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of

## 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 unsuccessfiul knee replacement or other procedure. · Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques. Additional Indicationsfor PosteriorStabilized (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 Indicationsfor Total Stabilizer (IS) Components: - Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indicationsfor 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. * Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. The Triathlon TS Total Knee System components are intended for cemented use only.

Source page: https://510kreport.com/device/K070095
Methodology: https://510kreport.com/methodology