510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190991Substantially Equivalent

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190991 is the FDA 510(k) clearance record for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment, a class II device, cleared for Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list 11 510(k) clearances for Howmedica Osteonics Corp. (Aka Stryker Orthopaedics), from to . As of , FDA records show 4 recalls naming K190991.

Clearance record

Decision date
Received
(122 days to decision)
Product code
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) 325 Corporate Dr., Mahwah NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBH

Trailing 12 months
9 clearances under product code MBH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MBH, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20262
October 20260