510(k) · Cleared
ClearedLINK Embrace Shoulder System- Anatomical Configuration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jun 21, 2021 as substantially equivalent to K161476 (Lima Corporate S.P.A., 2016) and 2 other predicates after an 87-day review. Its family tree reaches back 15 generations to 1991. 1 of the 108 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 21, 2021
- Review
- 87 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K911686 (1991). 107 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 108 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 2 generations backK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
- 1 generation backK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- This deviceK210899 LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021
Show all 15 generations
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 8 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 7 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 6 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 5 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 4 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 3 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 2 generations backK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
- 1 generation backK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- This deviceK210899 LINK Embrace Shoulder System- Anatomical 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 |
|---|---|---|---|---|---|
| −15 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −14 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −11 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −8 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −7 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −6 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −5 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −4 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −3 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| −2 | K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018 | — |
| −1 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
| 0 (this device) | K210899 | LINK Embrace Shoulder System- Anatomical 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 | 4 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K161476 | SMR Shoulder SystemSummary page 4…prosthesis; 21 CFR §888.3690, product code HSD Classification and Panel: Class II, Orthopedic / 87 Predicate Devices: Lima Corp. SMR Shoulder System:: K161476 [Primary Predicate] Biomet Corp. Comprehensive Shoulder System:: K060692.… | 2016 |
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 4…/ 87 Predicate Devices: Lima Corp. SMR Shoulder System:: K161476 [Primary Predicate] Biomet Corp. Comprehensive Shoulder System:: K060692. LINK GmbH & Co KG: LINK Embrace Shoulder System – Reverse Configuration… | 2006 |
| * | K200368 | LINK Embrace Shoulder System - Reverse ConfigurationSummary page 4…omprehensive Shoulder System:: K060692. LINK GmbH & Co KG: LINK Embrace Shoulder System – Reverse Configuration: K200368 Trade Name: LINK Embrace Shoulder System – Anatomical Configuration Device Description: The LINK Embrac… | 2021 |
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 8 companies; a new generation was cleared every 1.0 years on median.
- 36 of the 107 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty. Indications: • A severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis • Avascular necrosis of the humeral head • Deformity and/or limited motion • Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted…
Read the full statement (155 words)
General indications:
The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.
Indications:
• A severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
• Avascular necrosis of the humeral head
• Deformity and/or limited motion
• Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory
• Revision of a failed primary component
• Ununited humeral head fractures
• Cuff tear arthropathy (CTA Heads only)
The All Poly Glenoid Components are intended for cemented use.
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 are intended for cemented or cementless fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210899: LINK Embrace Shoulder System- Anatomical Configuration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210899
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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