TRIATHLON TRITANIUM TIBIAL BASEPLATE— 510(k) K123486

Clearance details

Applicant

Stryker

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2012-11-13

Decision date

2013-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

• K261462 — LANDMARK Total Knee System2026-09-08
• K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
• K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

• K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM2023-09-20
• K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®2023-05-19
• K230754 — L12 LED Light Source with AIM2023-04-11
• K230605 — 1788 4K Camera System with Advanced Imaging Modality2023-03-31
• K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)2023-02-23

Injury

6,545

Malfunction

2,023

Total

8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2461-2026 — TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.Class II·Ongoing·Howmedica Osteonics Corp.·20260519
• Z-2462-2026 — TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.Class II·Ongoing·Howmedica Osteonics Corp.·20260519
• Z-1237-2022 — Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500Class II·Ongoing·Howmedica Osteonics Corp.·20220330
• Z-1186-2021 — Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.Class II·Terminated·Howmedica Osteonics Corp.·20210210
• Z-2390-2016 — Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implantsClass II·Terminated·Stryker Howmedica Osteonics Corp.·20160623
• Z-0249-2016 — Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.Class II·Terminated·Stryker Howmedica Osteonics Corp.·20150929
• Z-1283-2015 — Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).Class II·Terminated·Stryker Howmedica Osteonics Corp.·20150212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123486.