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Panels › Orthopedic › Product code PHX · Class 2

Shoulder Prosthesis, Reverse Configuration

Regulation 888.3660

18510(k)s in 12 months (207 all time)
11recalls in 12 months (68 all time)
68recalls that name a 510(k)
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Top companies in PHX

DateFirm and productCodeLinked 510(k)
Aug 19, 2026restor3d Inc.
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product P
Open, Classified
PHXK243643
Jun 29, 2026Medacta Usa Inc
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 1
Open, Classified
PHXK250644
Jun 23, 2026Zimmer, Inc.
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Open, Classified
PHXK241043
Jun 23, 2026Zimmer, Inc.
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Open, Classified
PHXK241043
Jun 23, 2026Zimmer, Inc.
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Open, Classified
PHXK241043
Jun 23, 2026Zimmer, Inc.
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Open, Classified
PHXK241043
Jun 23, 2026Zimmer, Inc.
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Open, Classified
PHXK241043
Feb 24, 2026Encore Medical, LP
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Open, Classified
PHXK051075
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a componen
Open, Classified
PHXK042021
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Open, Classified
PHXK042021
Nov 17, 2025Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Open, Classified
PHXK042021
Sep 12, 2025Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-4
Open, Classified
PHXK223833
Sep 12, 2025Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE
Open, Classified
PHXK063569
Jun 25, 2025Limacorporate S.p.A
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Open, Classified
PHXK212800
Jun 25, 2025Limacorporate S.p.A
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
Open, Classified
PHXK212800
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified
PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified
PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified
PHXK233481
Jun 23, 2025Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices
Open, Classified
PHXK233481
May 8, 2025Tornier S.A.S.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Open, Classified
PHXK211359
May 22, 2024Tornier S.A.S.
Stryker Blueprint Software, Catalog #BPUE001.
Open, Classified
PHXK211359
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Open, Classified
PHXK180632
K182536
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Open, Classified
PHXK180632
K182536
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
Open, Classified
PHXK063569
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Open, Classified
PHXK093275
Mar 29, 2024Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
Open, Classified
PHXK093275
Jan 29, 2024FX SHOULDER
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Open, Classified
PHXK191146
Jan 19, 2024Tornier, Inc
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Open, Classified
PHXK183696
Jan 2, 2024Encore Medical, LP
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Completed
PHXK113756
Jan 2, 2024Encore Medical, LP
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Completed
PHXK051075
Dec 12, 2023Encore Medical, LP
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Open, Classified
PHXK112069
Nov 8, 2023Encore Medical, LP
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Open, Classified
PHXK051075
Oct 13, 2023Tornier, Inc
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Open, Classified
PHXK161742
Oct 12, 2023Encore Medical, LP
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Open, Classified
PHXK041066
Sep 19, 2023Encore Medical, LP
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Ne
Open, Classified
PHXK051075
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Terminated
PHXK101996
K170748
Dec 7, 2021DePuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Terminated
PHXK101996
K170748
May 11, 2021Exactech, Inc.
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat.
Completed
PHXK191561
Jan 15, 2021Biomet, Inc.
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Terminated
PHXK132239

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