Atlas FDA

SMR Reverse Liner

FDA 510(k) clearance K220792 · decided 2022-05-19

Clearance details

K-number
K220792
Device name
SMR Reverse Liner
Applicant
Lima Corporate S.P.A.
Decision
Substantially Equivalent
Date received
2022-03-18
Decision date
2022-05-19
Days to decision
62 days
Clearance type
Traditional
Product code
MBF
Device class
2
Regulation number
888.3670
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Villanova Di San Daniele Del Friuli, IT
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
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (K253592)Zimmer, Inc.2026-04-13
Identity Revision Humeral Stems (K251098)Zimmer, Inc.2025-08-11
Identity Shoulder System (K250848)Zimmer, Inc.2025-07-02
Identity Shoulder System (K240876)Zimmer, Inc.2024-06-12
PRIMA Humeral System; PRIMA TT Glenoid (K233712)Lima Corporate S.P.A.2024-01-11
SMR Hybrid Glenoid System (K231099)Lima Corporate S.P.A.2023-12-21
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831)Depuy Ireland UC2023-11-13
INHANCE™ Shoulder System, Sterile Single Use Instrumentation (K231516)Depuy Ireland UC2023-07-21
SMR Shoulder System (K223876)Lima Corporate S.P.A.2023-02-03
PRIMA TT Glenoid (K222427)Lima Corporate S.P.A.2022-10-06
Identity Shoulder System (K213856)Zimmer, Inc.2022-09-15
INHANCETM Hybrid Anatomic Glenoid Implant (K212933)Depuy Ireland UC2022-06-08

Recalls involving this device

No recalls on record reference this clearance.