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)
Top companies in PHX
| Company | 510(k)s | Recalls |
|---|---|---|
| Exactech, Inc. | 21 | 23 |
| Encore Medical L.P. | 18 | 16 |
| Tornier | 18 | 3 |
| Biomet Manufacturing Corp | 15 | 0 |
| Zimmer GmbH | 10 | 5 |
| DePuy Orthopaedics, Inc. | 6 | 8 |
| Medacta International S.A. | 13 | 0 |
| Arthrex, Inc. | 11 | 0 |
| Lima Corporate S.P.A. | 11 | 0 |
| Biomet Corporation | 4 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2026 | restor3d 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 |
PHX | K243643 |
| Jun 29, 2026 | Medacta 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 |
PHX | K250644 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040242 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040241 Open, Classified |
PHX | K241043 |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 Open, Classified |
PHX | K241043 |
| Feb 24, 2026 | Encore 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 |
PHX | K051075 |
| Nov 17, 2025 | Exactech, 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 |
PHX | K042021 |
| Nov 17, 2025 | Exactech, 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 |
PHX | K042021 |
| Nov 17, 2025 | Exactech, 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 |
PHX | K042021 |
| Sep 12, 2025 | Exactech, 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 |
PHX | K223833 |
| Sep 12, 2025 | Exactech, 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 |
PHX | K063569 |
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile Open, Classified |
PHX | K212800 |
| Jun 25, 2025 | Limacorporate S.p.A PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile Open, Classified |
PHX | K212800 |
| Jun 23, 2025 | Encore 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 |
PHX | K233481 |
| Jun 23, 2025 | Encore 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 |
PHX | K233481 |
| Jun 23, 2025 | Encore 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 |
PHX | K233481 |
| Jun 23, 2025 | Encore 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 |
PHX | K233481 |
| May 8, 2025 | Tornier S.A.S. Blueprint Software, BPUE001.
Intended for use by surgeons as a pre surgical planner for shoulder replacement. Open, Classified |
PHX | K211359 |
| May 22, 2024 | Tornier S.A.S. Stryker Blueprint Software, Catalog #BPUE001. Open, Classified |
PHX | K211359 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty Open, Classified |
PHX | K180632 K182536 |
| Mar 29, 2024 | Exactech, Inc. Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty Open, Classified |
PHX | K180632 K182536 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K063569 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K093275 |
| Mar 29, 2024 | Exactech, 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 |
PHX | K093275 |
| Jan 29, 2024 | FX SHOULDER Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 Open, Classified |
PHX | K191146 |
| Jan 19, 2024 | Tornier, Inc Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. Open, Classified |
PHX | K183696 |
| Jan 2, 2024 | Encore Medical, LP REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Completed |
PHX | K113756 |
| Jan 2, 2024 | Encore Medical, LP Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797 Completed |
PHX | K051075 |
| Dec 12, 2023 | Encore Medical, LP RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device. Open, Classified |
PHX | K112069 |
| Nov 8, 2023 | Encore Medical, LP RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component. Open, Classified |
PHX | K051075 |
| Oct 13, 2023 | Tornier, Inc stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 Open, Classified |
PHX | K161742 |
| Oct 12, 2023 | Encore Medical, LP REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130 Open, Classified |
PHX | K041066 |
| Sep 19, 2023 | Encore 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 |
PHX | K051075 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 16
Product Code: 110016100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 14
Product Code: 110014100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 12
Product Code: 110012100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 10
Product Code: 110010600 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 10
Part Number: 110010100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 8
Part Number: 110008600 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 8
Part Number: 110008100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 6
Part Number: 11000610 Terminated |
PHX | K101996 K170748 |
| May 11, 2021 | Exactech, 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 |
PHX | K191561 |
| Jan 15, 2021 | Biomet, Inc. Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. Terminated |
PHX | K132239 |
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