510(k) · Cleared
ClearedComprehensive Reverse Shoulder - E1 Polyethylene Claims
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Corporation · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 26, 2012 as substantially equivalent to K080642 (Biomet, Inc., 2008) and 1 other predicate after a 99-day review. Its family tree reaches back 12 generations to 1991. 1 of the 68 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Jul 26, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K911686 (1991). 53 ancestors in all, the oldest K790987 (1979). 14 later devices descend from it, 1 citing it directly. 1 of the 68 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 backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- This deviceK121183 Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation · 2012
- Descendant · cites it directly · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 2 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
- Descendant · 3 generations on · 1 of its ownK241817 InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
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 backK113121 Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
- This deviceK121183 Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation · 2012
Showing 5 of 14 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 14 · See all- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 2 generations on9descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on3descendants
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · 3 generations on1descendant
- K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 3 generations on1descendant
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 | K113121 | Comprehensive Reverse Shoulder | Biomet Manufacturing, Inc. | 2011 | — |
| 0 (this device) | K121183 | Comprehensive Reverse Shoulder - E1 Polyethylene Claims | Biomet Corporation | 2012 | — |
| +1 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +2 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +3 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
| +3 | 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 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 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? (2)
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 4…strained cemented prosthesis Classification panel Orthopedics Regulation 21 CFR 888.3660 Product Code(s) KWS, PAO Legally marketed Comprehenswe Reverse Shoulder System — K080642 device(s) to which Comp. Reverse Shoulder - E1® Humeral Bearings — K113121 equivalence is claimed Reason for 510(k) Claims langua… | 2008 |
| * | K113121 | Comprehensive Reverse ShoulderSummary page 4…CFR 888.3660 Product Code(s) KWS, PAO Legally marketed Comprehenswe Reverse Shoulder System — K080642 device(s) to which Comp. Reverse Shoulder - E1® Humeral Bearings — K113121 equivalence is claimed Reason for 510(k) Claims language . submission . Device description The Comprehensive® Reverse Shoulder is… | 2011 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this 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 21 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 18 of the 53 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202716 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 13 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. 2012, 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 Comprehensive® Reverse Shoulder is 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…
Read the full statement (154 words)
The Comprehensive® Reverse Shoulder is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121183: Comprehensive Reverse Shoulder - E1 Polyethylene Claims.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121183
Report an extraction error
Are you the manufacturer?
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