Atlas FDA

COMPREHENSIVE REVERSE SHOULDER

FDA 510(k) clearance K080642 · decided 2008-07-09

Clearance details

K-number
K080642
Device name
COMPREHENSIVE REVERSE SHOULDER
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
2008-03-06
Decision date
2008-07-09
Days to decision
125 days
Clearance type
Traditional
Product code
PHX
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Biomet

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
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

RecordFirmDate
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System recall (Z-1859-2017)Zimmer Biomet, Inc.2017-03-27
Comprehensive Reverse Shoulder System Humeral Tray Model 115340 recall (Z-1103-2017)Zimmer Biomet, Inc.2017-02-11
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision t recall (Z-1548-2013)Biomet, Inc.2013-06-17
Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, recall (Z-2541-2011)Biomet, Inc.2011-06-09
Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single recall (Z-2542-2011)Biomet, Inc.2011-06-09
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, sing recall (Z-2543-2011)Biomet, Inc.2011-06-09
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, singl recall (Z-2544-2011)Biomet, Inc.2011-06-09
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, si recall (Z-2545-2011)Biomet, Inc.2011-06-09
Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Ort recall (Z-2546-2011)Biomet, Inc.2011-06-09
Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP recall (Z-2547-2011)Biomet, Inc.2011-06-09
Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN recall (Z-2548-2011)Biomet, Inc.2011-06-09
Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm steril recall (Z-2549-2011)Biomet, Inc.2011-06-09
Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP recall (Z-2550-2011)Biomet, Inc.2011-06-09
Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, RE recall (Z-0712-2011)Biomet, Inc.2010-12-16
Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF recall (Z-0713-2011)Biomet, Inc.2010-12-16

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16