510(k) clearances

Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

Howmedica Osteonics Corp. dba Stryker Orthopaedics · Orthopedic

K261898Substantially EquivalentTraditionalKRO
Open FDA's page for this record
Third party flag
N
City
Mahwah
Advisory committee description
Orthopedic
Address 1
325 Corporate Dr.
Statement or summary
Summary
Product code
KRO
Zip code
07430
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
Decision date
2026-08-06
Decision code
SESE
Country code
US
Device name
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
Advisory committee
OR
Contact
Elizabeth Jodon
K number
K261898
State
NJ
Date received
2026-06-05
Review advisory committee
OR
Postal code
07430
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3510
Device class
2
Registration number
3007189546, 2249615, 1835251, 3013176080, 3000264985, 3010097171, 1834331, 3010220595, 3014252644, 3005751028, 3007539489, 3010057495, 3005061536, 3010386387, 3015516266, 3004635447, 3004748528, 9616680, 1833920, 3008110533, 3003639920, 1450662, 3009760038, 1833986, 3004153896, 2133928, 3016438694, 3002808022, 1825034, 3003387384, 9610726, 3013450937, 1000517406, 9681465, 1828464, 3015207155, 9610612, 1424263, 3035366890, 2183946 +97 more
FEI number
3007189546, 1000118610, 3002806315, 3013176080, 3000264985, 3010097171, 3010220595, 3014252644, 3002807172, 1000116116, 3005751028, 3007539489, 3010057495, 3005061536, 3010386387, 3015516266, 3004635447, 3004748528, 1000132037, 3002459190, 3002807113, 3008110533, 3003639920, 1450662, 3009760038, 1000221916, 3004153896, 1000306303, 3002287318, 3016438694, 3002808022, 1825034, 3003387384, 3013450937, 1000517406, 1000115656, 1828464, 3015207155, 3002807231, 3001451451 +97 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.