TRIATHLON TRITANIUM METAL-BACKED PATELLA— 510(k) K132624

Name: FDA 510(k) clearance K132624
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

Substantially Equivalent

Stryker Orthopaedics

FDA 510(k) clearance K132624 for TRIATHLON TRITANIUM METAL-BACKED PATELLA, Substantially Equivalent on 2013-11-26. Applicant: Stryker Orthopaedics. Device class: 2.

Clearance details

Applicant: Stryker Orthopaedics
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2013-08-22
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

More clearances from Stryker Orthopaedics

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K211703 — Insignia Hip Stem2021-08-16
K191414 — EXETER Centralizer, EXETER 2.5mm Plug2019-08-28
K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
K173849 — Triathlon Total Knee System2018-02-02
K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System2017-10-30

Adverse events under product code MBH

product code MBH

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 →

Recalls naming K132624

K-number listed on FDA's recall record

Z-1379-2021 — Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 RightClass II·Terminated·Howmedica Osteonics Corp.·20210305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132624.

Data sourced from openFDA. This site is unofficial and independent of the FDA.