# K141056: Triathlon Knee System Posterior Stabilized Components

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Aug 5, 2014 after 103 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: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K031729 (2003). 29 ancestors in all.
28 later devices descend from it; 13 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 8.
- K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert, Howmedica Osteonics Corp. (2004) Summary page 8.
- K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component, Howmedica Osteonics Corp. (2005) Summary page 8.
- K050539: Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert, Howmedica Osteonics Corp. (2005) Summary page 8.
- K051146: Triathlon Knee System, Howmedica Osteonics Corp. (2005) Summary page 8.
- K051380: Triathlon Press-Fit Total Knee System, Howmedica Osteonics Corp. (2005) Summary page 8.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 8.
- K061521: Triathlon Metal Backed Patella, Howmedica Osteonics Corp. (2006) Summary page 8.
- K062037: Triathlon Low Profile Tibial Tray, Howmedica Osteonics Corp. (2006) Summary page 8.
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 8.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 8.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 8.
- K072575: Triathlon Screw-Fixation Tibial Baseplate, Stryker Orthopaedics (2008) Summary page 8.
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P, Howmedica Osteonics Corp. (2013) Summary page 8.
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) Summary page 8.

## Cited in the summary but kept off the family tree
- K042067: Triathlon Knee System components. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 8.
- K132626: Pipeline Total Hip System (Line Extension), Pipeline Biotechnology (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own
- K223528: Triathlon® Hinge Knee System (2023), 4 descendants of its own

## Recalls of this device
- Sep 4, 2024 · Class II · Z-0023-2025: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
- Jul 1, 2021 · Class II · Z-2329-2021: The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert f
- Feb 10, 2021 · Class II · Z-1186-2021: Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there m
- 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
- Jan 30, 2018 · Class II · Z-1462-2018: Customers may receive the incorrect size implant from what is labeled on the box.
- Jan 12, 2018 · Class II · Z-1512-2018: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
- May 29, 2015 · Class II · Z-2389-2015: Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
- May 29, 2015 · Class II · Z-2360-2015: Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

## Indications for use
General Total Knee Arthroplasty (TKA) 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. General Total Knee Arthroplasty (TKR) Indications: Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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 Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant: Ligamentous instability requiring implant bearing surface geometries with increased constraint Absent or non-functioning posterior cruciate ligament Severe anteroposterior instability of the knee joint The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use. The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below: Indications for Use: Painful, disabling joint disease of the knee resulting from: degenerative arthritis, 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. 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/K141056
Methodology: https://510kreport.com/methodology