Panels › Orthopedic › Product code PHX · Class 2
Shoulder Prosthesis, Reverse Configuration
Regulation 888.3660
18510(k)s in 12 months (207 all time)
12recalls in 12 months (69 all time)
69recalls 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) |
|---|---|---|---|
| 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 |
| Sep 25, 2020 | Exactech, Inc. Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. Terminated |
PHX | K092900 K101909 |
| Sep 25, 2020 | Exactech, Inc. Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. Terminated |
PHX | K092900 K101909 |
| Sep 2, 2020 | Biomet, Inc. Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis
item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder p Terminated |
PHX | K120121 K193373 |
| Aug 24, 2020 | Exactech, Inc. Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. Terminated |
PHX | K063569 |
| Aug 24, 2020 | Exactech, Inc. Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. Terminated |
PHX | K063569 |
| Aug 7, 2020 | Encore Medical, LP RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440 Open, Classified |
PHX | K141006 |
| Aug 7, 2020 | Encore Medical, LP RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Open, Classified |
PHX | K141006 |
| May 11, 2020 | Biomet, Inc. Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503
(10)814100, (01)00880304829503
(10)570640, (01)00880304829503
(10)728890, (01)00880304829503
(10)977300 Terminated |
PHX | K152754 |
| Apr 17, 2020 | Biomet, Inc. Extremities
Item Number:
1)113954 Hybrid Glenoid Glenoid Base, 4 MM
2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard
3) XL-115364 Comprehensive Reverse Sh Terminated |
PHX | K080642 |
| Mar 13, 2020 | Biomet, Inc. Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral sid Terminated |
PHX | K080642 |
| Feb 25, 2020 | Biomet, Inc. Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disab Terminated |
PHX | K120121 |
| Dec 3, 2019 | Exactech, Inc. Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with d Terminated |
PHX | K101909 |
| Dec 3, 2019 | Exactech, Inc. Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with de Terminated |
PHX | K101909 |
| Oct 18, 2019 | Tornier, Inc Aequalis Ascend Flex Humeral Stem:
Part Number UDI
DWF601A 3700386944475
DWF601B 3700386944482
DWF601C 3700386944499
DWF602A 3700386944505
DWF602B 3700386944512
DWF602C 3700386944529
DWF603A 370038694 Terminated |
PHX | K122698 |
| Dec 5, 2018 | Exactech, Inc. Equinoxe Preserve Humeral Stem, 8mm
Product Usage:
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatom Terminated |
PHX | K162726 |
| Mar 5, 2018 | Encore Medical, Lp AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument.
Product Usage:
The humeral socket shell trial is u Terminated |
PHX | K141990 |
| Jan 9, 2016 | Encore Medical, Lp AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Should Terminated |
PHX | K141990 |
| Oct 16, 2015 | Encore Medical, Lp AltiVate Humeral Socket Shell Trial, Part Number 804-06-052
The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemente Terminated |
PHX | K141990 |
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