Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment— 510(k) K190991
Substantially EquivalentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)
FDA 510(k) clearance K190991 for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment, Substantially Equivalent on 2019-08-15. Applicant: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code MBH
view allMore clearances from Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . 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 K190991
K-number listed on FDA's recall record- Z-2757-2019 — TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
- Z-2758-2019 — TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
- Z-2759-2019 — TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:
- Z-2760-2019 — TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190991.
Data sourced from openFDA. This site is unofficial and independent of the FDA.