510(k) · Cleared
ClearedArthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Sep 28, 2018 as substantially equivalent to K172371 (Arthrex, Inc., 2018) after a 60-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Sep 28, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K911686 (1991). 45 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK172371 Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc. · 2018
- This deviceK182039 Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid…Arthrex, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 4 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK172371 Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc. · 2018
- This deviceK182039 Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid…Arthrex, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −7 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −6 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −5 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −4 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −3 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −2 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −1 | K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | Arthrex, Inc. | 2018 | — |
| 0 (this device) | K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Arthrex, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172371 | Arthrex UNIVERS REVERS COATED BASEPLATESummary page 4…Prosthesis, Shoulder, semi-constrained metal/polymer, uncemented, CFR 888.3670 Regulatory Class II Predicate Device Primary – K172371: Arthrex Univers Revers Coated Baseplate Reference – K161120: Lima SMR TT Metal Back Glenoid… | 2018 |
| † | K161120 | SMR TT Metal Back Glenoid, Bone Graft instruments | 2017 |
| † | K162068 | ARROW Anatomical Porous glenoid | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 45 ancestors have a recall of any class.
- 1 other device also cites its predicate K172371.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be…
Read the full statement (265 words)
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic or dysplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex Univers II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182039: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182039
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026