Atlas FDA

ZIMMER R TOTAL SHOULDER II

FDA 510(k) clearance K790987 · decided 1979-06-22

Clearance details

K-number
K790987
Device name
ZIMMER R TOTAL SHOULDER II
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1979-05-25
Decision date
1979-06-22
Days to decision
28 days
Clearance type
Traditional
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Zimmer

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713)Exactech, Inc.2025-12-01
Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686)Tornier, Inc.2025-10-30
AGILON® XO Shoulder Replacement System (K241944)Implantcast GmbH2025-03-10
InSet Total Shoulder System (K241817)Shoulder Innovations, Inc.2025-02-11
AGILON® XO Shoulder Replacement System (K231657)Implantcast GmbH2024-02-16
Comprehensive Segmental Revision System(SRS) (K223631)Biomet Orthopedics2023-07-12
AGILON XO Shoulder System (K222482)Implantcast GmbH2022-09-28
LINK Embrace Shoulder System- Anatomical Configuration (K210899)Waldemar Link GmbH & Co. KG2021-06-21
TiN Coated Humeral Head (K191698)Fx Shoulder USA, Inc.2020-07-16
Shoulder Innovations Total Shoulder System (K192365)Shoulder Innovations, Inc.2019-11-29
Catalyst OrthoScience CSR Shoulder System (K191811)Catalyst Orthoscience, Inc.2019-09-11
Signature ONE System (K190595)Orthosoft Inc (D/B/A Zimmer Cas)2019-06-05

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