510(k) · Cleared
Recalled · Class II · 2020Comprehensive Convertible Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 9, 2013 as substantially equivalent to K113254 (Lima Corporate S.P.A., 2012) and 3 other predicates after a 236-day review. Its family tree reaches back 12 generations to 1991. 1 of the 84 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2013
- Review
- 236 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K911686 (1991). 75 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 3 citing it directly. 1 of the 84 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled
- This deviceK130390 Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- Descendant · cites it directly · 2 of its ownK211729 Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp · 2021
- Descendant · 2 generations on · 1 of its ownK214001 Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp · 2023
- Descendant · 3 generations on · 0 of its ownK252404 Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics · 2026
- Descendant · 2 generations on · 0 of its ownK231445 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120121 Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc. · 2012 · Recalled
- This deviceK130390 Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 5 of 8 · See all- K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021 · cites it directly3descendants
- K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp · 2021 · cites it directly2descendants
- K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp · 2023 · 2 generations on1descendant
- K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics · 2026 · 3 generations on0descendants
- K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −1 | K120121 | Comprehensive Reverse Shoulder-Mini Baseplate | Biomet, Inc. | 2012 | 4 |
| 0 (this device) | K130390 | Comprehensive Convertible Glenoid | Biomet Manufacturing, Inc. | 2013 | — |
| +1 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
| +1 | K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | 2021 | — |
| +2 | K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Biomet Manufacturing Corp | 2023 | — |
| +3 | K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026 | — |
| +2 | K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 4 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsSummary page 4…-constrained porous- coated uncemented prosthesis Classification panel Orthopedics Legally marketed device(s) to which equivalence is claimed SMR™ Modular Glenoids (K113254) BtoModular Shoulder System (K892119, K030710) Comprehensuve Reverse Shoulder (K080642, K120121) Reason for 510{k) submission… | 2012 |
| Kept off the family tree | K892119 | FDA’s K892119 is Quik-Dot C Reactive Protein Our OCR of the scanned summary read K892119, FDA’s number for Quik-Dot C Reactive Protein (Ampcor, Inc.), which shares no word with the summary’s name for the device, “Bio-Modular Shoulder System”, apart from generic ones like “system”. Kept off the family tree. Summary page 4…d prosthesis Classification panel Orthopedics Legally marketed device(s) to which equivalence is claimed SMR™ Modular Glenoids (K113254) BtoModular Shoulder System (K892119, K030710) Comprehensuve Reverse Shoulder (K080642, K120121) Reason for 510{k) submission New device The Comprehensive Converti… | 1989 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 4…sis Classification panel Orthopedics Legally marketed device(s) to which equivalence is claimed SMR™ Modular Glenoids (K113254) BtoModular Shoulder System (K892119, K030710) Comprehensuve Reverse Shoulder (K080642, K120121) Reason for 510{k) submission New device The Comprehensive Convertible Gleno… | 2003 |
| * | K080642 | Comprehensive Reverse ShoulderSummary page 4…egally marketed device(s) to which equivalence is claimed SMR™ Modular Glenoids (K113254) BtoModular Shoulder System (K892119, K030710) Comprehensuve Reverse Shoulder (K080642, K120121) Reason for 510{k) submission New device The Comprehensive Convertible Glenoid Baseplate is round, truncated on the a… | 2008 |
| * | K120121 | Comprehensive Reverse Shoulder-Mini BaseplateSummary page 4…rketed device(s) to which equivalence is claimed SMR™ Modular Glenoids (K113254) BtoModular Shoulder System (K892119, K030710) Comprehensuve Reverse Shoulder (K080642, K120121) Reason for 510{k) submission New device The Comprehensive Convertible Glenoid Baseplate is round, truncated on the anterior a… | 2012 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0619-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 27 of the 75 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200368 (Waldemar Link GmbH & Co. KG, 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K113254.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular. necrosis. Rheumatoid arthritis. Revision where other devices or treatments have failed. Correction of functional deformity. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be…
Read the full statement (197 words)
Anatomic Applications
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular.
necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Fractures of the proximal humerus, where other methods of treatment are deemed
inadequate.
Difficult clinical management problems, including cuff arthropathy, where other methods of
treatment may not be suitable or may be inadequate. :
Reverss Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a
grossly deficient rotator cuff with severe arthropathy and/or previousty failed shoulder joint
replacement with a grossly deficient rotator cuff. The patient must be anatomically and
structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fraclure, or revision total
shoulder replacement for the relief of pain and significant disability due to gross rotator cuff
deficiency.
Comprehensive Convertible Glenoid Baseplate components are intended for cementless
applications with the addition of screw fixation.
Interlok finish humeral stems are intended for cemented use and the MacroBond coated
humeral stems are intended for press-fit or cemented application. Humeral components with
porous coated surface coating are indicated for either cemented or.uncemented biological
fixation applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130390: Comprehensive Convertible Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130390
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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