Atlas FDA

Zimmer Segmental System XT Components

FDA 510(k) clearance K150028 · decided 2015-02-06

Clearance details

K-number
K150028
Device name
Zimmer Segmental System XT Components
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2015-01-07
Decision date
2015-02-06
Days to decision
30 days
Clearance type
Special
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, 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
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898)Howmedica Osteonics Corp. dba Stryker Orthopaedics2026-08-06
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ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043)Microport Orthopedics, Inc.2024-04-01
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
EVOLUTION® Hinge Knee System (K230563)Microport Orthopedics, Inc.2023-09-27
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
Triathlon® Hinge Knee System (K223528)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
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.

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13