Atlas FDA

Alliance Augmented Glenoid

FDA 510(k) clearance K193180 · decided 2020-02-24

Clearance details

K-number
K193180
Device name
Alliance Augmented Glenoid
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
2019-11-18
Decision date
2020-02-24
Days to decision
98 days
Clearance type
Traditional
Product code
KWS
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Tornier Perform Advanced Glenoid (K260721)Tornier, Inc.2026-07-22
AETOS Shoulder System - CONCELOC Glenoids (K254084)Smith & Nephew, Inc.2026-04-06
Catalyst F1x Shoulder System (K252418)Catalyst Orthoscience, Inc.2025-11-06
AETOS Shoulder System Meta Humeral Prosthesis Size 0 (K252416)Smith & Nephew, Inc.2025-10-29
MyShoulder Planner (5.3SSWPL) (K241292)Medacta International S.A.2025-01-30
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (K241878)Stryker Corporation (Tornier, Inc.)2024-12-06
Tornier Humeral Reconstruction System (Tornier HRS) (K241609)Stryker Corporation (Tornier, Inc.)2024-09-10
Arthrex Univers Apex OptiFit Humeral Stem (K230513)Arthrex, Inc.2023-09-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
AETOS Shoulder System (K220847)Smith & Nephew, Inc.2023-01-03
Catalyst EA Convertible Stemmed Shoulder (K222317)Catalyst Orthoscience, Inc.2022-11-10

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