Atlas FDA

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

FDA 510(k) clearance K162325 · decided 2017-03-06

Clearance details

K-number
K162325
Device name
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
Applicant
Exactech, Inc.
Decision
Substantially Equivalent
Date received
2016-08-19
Decision date
2017-03-06
Days to decision
199 days
Clearance type
Special
Product code
PHX
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Gainesville, FL, 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
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.

PMA approvals by this applicant

RecordFirmDate
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021)Exactech, Inc.2017-04-03
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020)Exactech, Inc.2016-09-28
NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019)Exactech, Inc.2016-07-21
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017)Exactech, Inc.2016-04-26
NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018)Exactech, Inc.2015-12-30
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016)Exactech, Inc.2014-06-18
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015)Exactech, Inc.2013-02-07
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014)Exactech, Inc.2012-12-05