Atlas FDA

JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

FDA 510(k) clearance K133152 · decided 2014-01-22

Clearance details

K-number
K133152
Device name
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Applicant
Stanmore Implants Worldwide , Ltd.
Decision
Substantially Equivalent
Date received
2013-11-22
Decision date
2014-01-22
Days to decision
61 days
Clearance type
Special
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
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Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)Stryker2023-05-19
Modular Rotating Hinge Knee Systems and Compatible Components (K223069)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
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LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03

Recalls involving this device

No recalls on record reference this clearance.