510(k) · Cleared
Recalled · Class II · 2020Comprehensive® Reverse Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Apr 15, 2020 as substantially equivalent to K080642 (Biomet, Inc., 2008) and 6 other predicates after a 132-day review. Its family tree reaches back 13 generations to 1991. 1 of the 99 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 15, 2020
- Review
- 132 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 13 generations to K911686 (1991). 78 ancestors in all, the oldest K790987 (1979). 20 later devices descend from it, 7 citing it directly. 1 of the 99 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- This deviceK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020
- Descendant · cites it directly · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · cites it directly · 2 of its ownK233148 Augment Off-Axis Instrument SystemFix Surgical · 2024
- Descendant · 2 generations on · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
- Descendant · cites it directly · 1 of its ownK243643 restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK241817 InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 1 generation backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- This deviceK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020
Showing 5 of 20 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 20 · See all- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · cites it directly9descendants
- K233148Augment Off-Axis Instrument SystemFix Surgical · 2024 · cites it directly2descendants
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · 2 generations on1descendant
- K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D · 2025 · cites it directly1descendant
- K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −1 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| 0 (this device) | K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 | — |
| +1 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +1 | K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024 | — |
| +2 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
| +1 | K243643 | restor3d Reverse Total Shoulder Arthroplasty System | Restor3D | 2025 | 1 |
| +2 | K241817 | InSet Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 9 | 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? (7)
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 |
|---|---|---|---|
| * | K080642 | Comprehensive Reverse ShoulderSummary page 5…vice(s): Predicates 510(k) Number Comprehensive Reverse Shoulder K080642 - Primary Comprehensive Reverse Shoulder – Humera… | 2008 |
| * | K113069 | Comprehensive Reverse Shoulder Humeral TraySummary page 5…K080642 - Primary Comprehensive Reverse Shoulder – Humeral Trays K113069 Comprehensive Reverse Shoulder – E1 (Poly) Humeral Bearings K113121 Comprehensive Reverse Shoulder – Mini Bas… | 2012 |
| * | K113121 | Comprehensive Reverse ShoulderSummary page 5…Primary Comprehensive Reverse Shoulder – Humeral Trays K113069 Comprehensive Reverse Shoulder – E1 (Poly) Humeral Bearings K113121 Comprehensive Reverse Shoulder – Mini Baseplate K120121 Comprehensive Reverse Shoulder – Titanium… | 2011 |
| * | K120121 | Comprehensive Reverse Shoulder-Mini BaseplateSummary page 5…K113069 Comprehensive Reverse Shoulder – E1 (Poly) Humeral Bearings K113121 Comprehensive Reverse Shoulder – Mini Baseplate K120121 Comprehensive Reverse Shoulder – Titanium Glenospheres K131353… | 2012 |
| * | K131353 | Comprehensive Reverse Shoulder - Titanium GlenosphereSummary page 5…K113121 Comprehensive Reverse Shoulder – Mini Baseplate K120121 Comprehensive Reverse Shoulder – Titanium Glenospheres K131353 K193373 Page 2/5 Comprehensive Re… | 2013 |
| * | K132239 | Comprehensive Reverse Shoulder ScrewsSummary page 6…== K193373 Page 2/5 Comprehensive Reverse Shoulder – Screws K132239 Comprehensive Vault Reconstruction System (VRS) K152754 Purpose and Device The purpose of… | 2013 |
| * | K152754 | Comprehensive Vault Reconstruction System (VRS)Summary page 6…Page 2/5 Comprehensive Reverse Shoulder – Screws K132239 Comprehensive Vault Reconstruction System (VRS) K152754 Purpose and Device The purpose of this submission is: Description: • To provide a cumulative assessment… | 2016 |
What descends from it? (20)
See all 207 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212737 | INHANCE™ Reverse Shoulder System | 2022 | 9 |
| K233148 | Augment Off-Axis Instrument System | 2024 | 2 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | 2025 | 1 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | 2024 | 1 |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | 2023 | 1 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | 2026 | 0 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral… | 2026 | 0 |
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. |
| Sep 2, 2020 | Class II | Z-0093-2021 | Packaging process control | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates… |
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 29 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 78 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212737 (Depuy Ireland UC, 2022) has gone furthest, with 9 descendants of its own.
- 23 other devices also cite its predicate K080642.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously 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, fracture, or…
Read the full statement (367 words)
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously 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, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application 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 applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously 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, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application 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 applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193373: Comprehensive® Reverse Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193373
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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