510(k) · Cleared
ClearedLINK® Embrace Shoulder System - Reverse Configuration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 18, 2021 as substantially equivalent to K200368 (Waldemar Link GmbH & Co. KG, 2021) and 6 other predicates after a 59-day review. Its family tree reaches back 17 generations to 1991. 1 of the 147 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 18, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 17 generations to K911686 (1991). 146 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 147 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations between
- 3 generations backK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
- 2 generations backK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- 1 generation backK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- This deviceK212992 LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
Show all 17 generations
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- 4 generations backK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
- 3 generations backK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
- 2 generations backK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- 1 generation backK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- This deviceK212992 LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −16 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −13 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −10 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −9 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −8 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −7 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −6 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K120739 | Aequalis Adjustable Modular Reverse Shoulder System | Tornier, Inc. | 2012 | — |
| −4 | K130050 | Titan Reverse Shoulder System | Ascension Orthopedic | 2013 | — |
| −3 | K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2016 | — |
| −2 | K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
| −1 | K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
| 0 (this device) | K212992 | LINK® Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K200368 | LINK Embrace Shoulder System - Reverse ConfigurationSummary page 4…ification Class II, Orthopedic / 87 and Panel: Predicate Waldemar Link GmbH & Co KG LINK Embrace Total Shoulder System – Devices: Reverse Configuration [K200368 – Primary Predicate] Lima Corp. SMR Reverse Shoulder System [K110598]: Additional 510ks for the… | 2021 |
| * | K110598 | SMR Reverse Shoulder SystemSummary page 4…Co KG LINK Embrace Total Shoulder System – Devices: Reverse Configuration [K200368 – Primary Predicate] Lima Corp. SMR Reverse Shoulder System [K110598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder Syste… | 2011 |
| * | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Summary page 4…e Configuration [K200368 – Primary Predicate] Lima Corp. SMR Reverse Shoulder System [K110598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder System K173717, K181999, K190588 Reason for Adds… | 2010 |
| * | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Summary page 4…ration [K200368 – Primary Predicate] Lima Corp. SMR Reverse Shoulder System [K110598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder System K173717, K181999, K190588 Reason for Adds Modular… | 2011 |
| * | K173717 | Integra TITAN Reverse Shoulder SystemSummary page 4…ulder System [K110598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder System K173717, K181999, K190588 Reason for Adds Modular Humeral Stem Components to the predicate Embrace Total Submission Shoulder… | 2018 |
| * | K181999 | Integra TITAN Reverse Shoulder SystemSummary page 4…tem [K110598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder System K173717, K181999, K190588 Reason for Adds Modular Humeral Stem Components to the predicate Embrace Total Submission Shoulder System… | 2018 |
| * | K190588 | Integra TITAN Reverse Shoulder SystemSummary page 4…598]: Additional 510ks for the system include K100858, K101263 Integra Titan Reverse Shoulder System K173717, K181999, K190588 Reason for Adds Modular Humeral Stem Components to the predicate Embrace Total Submission Shoulder System Device… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 40 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K200368.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty. Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient’s joint must be anatomically and structurally suited to receive the implants. The Reverse Glenoid Baseplate component is intended…
Read the full statement (153 words)
General indications:
The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient’s joint must be anatomically and structurally suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cemented or cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.
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/K212992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212992: LINK® Embrace Shoulder System - Reverse Configuration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212992
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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