ClearanceBrief
510(k) K123486 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

TRIATHLON TRITANIUM TIBIAL BASEPLATE

ApplicantStryker, Mahwah NJ, US
DecisionSubstantially Equivalent, May 3, 2013
ReceivedNov 13, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K123486

DateFirm and productCodeLinked 510(k)
Jun 17, 2026Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Open, Classified		 MBHNone listed
Jun 17, 2026Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Open, Classified		 MBHNone listed
Jun 3, 2022Howmedica Osteonics Corp.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
Open, Classified		 JWHNone listed
Feb 10, 2021Howmedica Osteonics Corp.
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Terminated		 MBHNone listed
Jun 23, 2016Stryker Howmedica Osteonics Corp.
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, t
Terminated		 MBHNone listed
Nov 9, 2015Stryker Howmedica Osteonics Corp.
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 capt
Terminated		 JWHNone listed
Mar 16, 2015Stryker Howmedica Osteonics Corp.
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 resect
Terminated		 MBHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.