Atlas FDA

Anatomical Shoulder System

FDA 510(k) clearance K193099 · decided 2020-01-29

Clearance details

K-number
K193099
Device name
Anatomical Shoulder System
Applicant
Zimmer GmbH
Decision
Substantially Equivalent
Date received
2019-11-07
Decision date
2020-01-29
Days to decision
83 days
Clearance type
Traditional
Product code
PHX
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Winterthur, CH
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
Veritas Shoulder System (K260556)Restor3D2026-07-01
Augment Off-Axis Instrument System (K261683)Zimmer, Inc.2026-06-16
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (K260102)Stryker Corporation (Tornier, Inc.)2026-06-12
MSS - Humeral reverse liners extension (K261016)Medacta International, SA2026-06-10
Veritas Reverse Total Shoulder System (K253992)Restor3D2026-05-07
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (K252404)Biomet Orthopedics2026-04-15
Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
InSet Reverse Total Shoulder System (K254128)Shoulder Innovations, Inc.2026-04-13
Blueprint Patient-Specific Instrumentation (K253674)Stryker Corporation (Tornier, S.A.S.)2026-04-03
INHANCE™ Reverse Shoulder System (K253624)Depuy Ireland UC2026-03-11
MSS - Monobloc stem (K250644)Medacta International S.A.2026-02-03
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (K252352)Lima Corporate S.P.A.2026-01-22

Recalls involving this device

No recalls on record reference this clearance.