510(k) Report

510(k) · Cleared

Cleared

LINK Embrace Shoulder System - Reverse Configuration

K200368510(k) TraditionalCleared Feb 5, 2021357-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Waldemar Link GmbH & Co. KG · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Feb 5, 2021 as substantially equivalent to K110598 (Lima Corporate S.P.A., 2011) and 7 other predicates after a 357-day review. Its family tree reaches back 14 generations to 1991. 1 of the 106 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
Feb 5, 2021
Review
357 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
8

Its longest line of descent runs back 14 generations to K911686 (1991). 102 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 3 citing it directly. 1 of the 106 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 2 other ancestors2012: 4 other ancestors2011: 4 other ancestors2010: 1 other ancestor2014: 1 other ancestor2009: 1 other ancestor2008: 5 other ancestors2007: 4 other ancestors2006: 4 other ancestors2005: 7 other ancestors2004: 2 other ancestors2003: 2 other ancestors2000: 6 other ancestors2001: 4 other ancestors1999: 5 other ancestors1998: 3 other ancestors1997: 2 other ancestors1996: 7 other ancestors1994: 6 other ancestors1992: 2 other ancestors1987: 4 other ancestors1995: 2 other ancestors1988: 1 other ancestor2002: 2 other ancestors1993: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1980: 2 other ancestors1979: 1 other ancestor1991: 1 other ancestor2021: 2 descendants cleared2023: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K093803 · Bio-Modular Reverse Sholder · Biomet Manufacturing Corp · 2010K131353 · Comprehensive Reverse Shoulder - Titanium Glenosphere · Biomet Manufacturing Corp · 2013K181611 · Comprehensive Reverse Shoulder System · Biomet Manufacturing Corp · 201819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 14 other ancestors3 generations back: 30 other ancestors4 generations back: 12 other ancestors5 generations back: 18 other ancestors6 generations back: 8 other ancestors 1 generation forward: 3 descendants K181611 · Comprehensive Reverse Shoulder System · Biomet Manufacturing Corp · 2018K131353 · Comprehensive Reverse Shoulder - Titanium Glenosphere · Biomet Manufacturing Corp · 2013K093803 · Bio-Modular Reverse Sholder · Biomet Manufacturing Corp · 2010K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 10 generations between
  3. 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
  4. 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  5. 1 generation backK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
  6. This deviceK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
  7. Descendant · cites it directly · 0 of its ownK231445 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023
  8. Descendant · cites it directly · 0 of its ownK212992 LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
  9. Descendant · cites it directly · 0 of its ownK210899 LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021
Show all 14 generations
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 3 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
  13. 2 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  14. 1 generation backK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
  15. This deviceK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulderdirect predicate · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023 · cites it directly0descendants
  • K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021 · cites it directly0descendants
  • K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−13K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−12K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−11K021478Delta ShoulderDepuy, Inc.2003—
−10K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−7K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−6K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp2010—
−2K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp2013—
−1K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp2018—
0 (this device)K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG2021—
+1K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG2023—
+1K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG2021—
+1K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198740
198810
198910
199110
199220
199310
199460
199520
199670
199720
199830
199950
200060
200140
200220
200320
200420
200570
200640
200740
200850
200910
201010
201140
201240
201320
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202310
FIG. 1 — Lineage of K200368, 1991–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K110598SMR Reverse Shoulder System
Summary page 4
…i-Constrained, Metal/Polymer + Additive, Cemented Predicate Primary Predicate: Devices: Lima Corp. SMR Reverse Shoulder System: K110598 Additional Predicates: Lima Corp. SMR Reverse Shoulder System: K100858, K101263…
Lima Corporate S.P.A.20111
*K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…
Summary page 4
…Devices: Lima Corp. SMR Reverse Shoulder System: K110598 Additional Predicates: Lima Corp. SMR Reverse Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K13…
Lima-Lto S.P.A.20102
*K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…
Summary page 4
…Lima Corp. SMR Reverse Shoulder System: K110598 Additional Predicates: Lima Corp. SMR Reverse Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K11…
Lima-Lto S.P.A.2011—
*K181611Comprehensive Reverse Shoulder System
Summary page 4
…tes: Lima Corp. SMR Reverse Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K113069, K080642, K132239 Device Humeral Stems (Ti6Al4V) are available in monoblock d…
Biomet Manufacturing Corp2018—
*K130390Comprehensive Convertible Glenoid
Summary page 4
…Corp. SMR Reverse Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K113069, K080642, K132239 Device Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature Descripti…
Biomet Manufacturing, Inc.20131
*K113069Comprehensive Reverse Shoulder Humeral Tray
Summary page 4
…R Reverse Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K113069, K080642, K132239 Device Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature Description:…
Biomet Manufacturing Corp2012—
*K080642Comprehensive Reverse Shoulder
Summary page 4
…Shoulder System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K113069, K080642, K132239 Device Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature Description: a proxi…
Biomet, Inc.2008Class I
*K132239Comprehensive Reverse Shoulder Screws
Summary page 4
…System: K100858, K101263 Biomet Corp. Comprehensive Reverse Shoulder System: K181611, K130390, K113069, K080642, K132239 Device Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature Description: a proximal modul…
Biomet Manufacturing Corp20132

Also cleared against K110598: 11 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230
K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210
K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210

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 30 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
  • 34 of the 102 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K231445 (Waldemar Link GmbH & Co. KG, 2023) has gone furthest, with 0 descendants of its own.
  • 11 other devices also cite its predicate K110598.

How does its category compare?

All PHX devices

PHX 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

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

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 Baseplate is intended for cementless fixation with the…

Read the full statement (114 words)

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 Baseplate 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 are intended for cemented or cementless fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K110598

11 other devices cite the same predicate.

  • K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA…Encore Medical L.P. · 2025
  • K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 20222 recalls
  • K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
  • K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
  • K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019
  • K172456Bone Screws 6.5mmLima Corporate S.P.A. · 20182 recalls

More from Waldemar Link GmbH & Co. KG

43 FDA decisions under this applicant name. See the company

  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG · 2025
  • K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
  • K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2023

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K200368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200368: 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/K200368

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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