510(k) Report

510(k) · Cleared

Cleared

GLOBAL ICON Stemless Shoulder System

K212683510(k) TraditionalCleared Jan 19, 2022148-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

Depuy (Ireland) · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Cleared on Jan 19, 2022 as substantially equivalent to K171858 (Zimmer GmbH, 2017) and 4 other predicates after a 148-day review. Its family tree reaches back 7 generations to 1991.

Decided
Jan 19, 2022
Review
148 days
Class
Class II
Product code
PKC
Recalls
None
Predicates
5

Its longest line of descent runs back 7 generations to K911686 (1991). 23 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 2 other ancestors1992: 1 other ancestor1996: 4 other ancestors1995: 1 other ancestor1993: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1991: 2 other ancestorsReference device: K033516 · Depuy Global Cap HA Resurfacing Shoulder Humeral Heads · DePuy Orthopaedics, Inc. · 2003Reference device: K192919 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2019K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) K060988 · Total and Hemi Shoulder System · Dvo Extremity Solutions, LLC · 2006 · recalledK103007 · Affiniti Total and Hemi-Shoulder System · Tornier, Inc. · 2010K143552 · Simpliciti Shoulder System · Tornier, Inc. · 2015K171858 · Sidus Stem-Free Shoulder · Zimmer GmbH · 2017 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 10 other ancestors4 generations back: 2 other ancestors K171858 · Sidus Stem-Free Shoulder · Zimmer GmbH · 2017 · recalledK143552 · Simpliciti Shoulder System · Tornier, Inc. · 2015K103007 · Affiniti Total and Hemi-Shoulder System · Tornier, Inc. · 2010K060988 · Total and Hemi Shoulder System · Dvo Extremity Solutions, LLC · 2006 · recalledK992065 · 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. · 1991−50
  1. Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 4 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
  5. 3 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
  6. 2 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
  7. 1 generation backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
  8. This deviceK212683 GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland) · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−6K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−5K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−4K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200613
−3K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.2010—
−2K143552Simpliciti Shoulder SystemTornier, Inc.2015—
−1K171858Sidus Stem-Free ShoulderZimmer GmbH20173
0 (this device)K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
198710
198910
199120
199210
199310
199510
199640
199820
200110
FIG. 1 — Lineage of K212683, 1991–2022Source: 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.

Planning a device in PKC? 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 PKC device

  1. #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 17 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? (5)

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
*K171858Sidus Stem-Free Shoulder
Summary page 5
…rthopedics Regulation 21 CFR 888.3660 Product Code(s) PKC Legally marketed device(s) Primary predicate: Zimmer Sidus Stem-Free Shoulder (K171858) to which equivalence is Additional predicates: Tornier Simpliciti™ Shoulder System claimed (K143552),…
Zimmer GmbH20173
*K143552Simpliciti Shoulder System
Summary page 5
…redicate: Zimmer Sidus Stem-Free Shoulder (K171858) to which equivalence is Additional predicates: Tornier Simpliciti™ Shoulder System claimed (K143552), Global Advantage Shoulder System (K011047, K992065, K984541). Referen…
Tornier, Inc.2015—
*K011047Global Advantage Humeral Stem with Porocoat
Summary page 5
…171858) to which equivalence is Additional predicates: Tornier Simpliciti™ Shoulder System claimed (K143552), Global Advantage Shoulder System (K011047, K992065, K984541). Reference devices: GLOBAL CAP HA Humeral Heads (K03…
DePuy Orthopaedics, Inc.2001—
*K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head
Summary page 5
…o which equivalence is Additional predicates: Tornier Simpliciti™ Shoulder System claimed (K143552), Global Advantage Shoulder System (K011047, K992065, K984541). Reference devices: GLOBAL CAP HA Humeral Heads (K033516)…
DePuy Orthopaedics, Inc.1999—
*K984541Global FX Humeral Stem, Global Advantage Humeral Head
Summary page 5
…predicates: Tornier Simpliciti™ Shoulder System claimed (K143552), Global Advantage Shoulder System (K011047, K992065, K984541). Reference devices: GLOBAL CAP HA Humeral Heads (K033516) and Pinnacle…
DePuy Orthopaedics, Inc.1999—
†K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003—
†K192919Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2019—

Also cleared against K171858: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
  • 5 of the 23 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K171858.

How does its category compare?

All PKC devices

PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · PKC

1in 2025

2015: 12017: 12018: 12019: 12020: 42021: 22022: 32023: 12024: 32025: 12026 (partial year): 2
2007high 4 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PKC

167in 2024

2020: 116 days median2022: 148 days median2024: 167 days median
2007high 167 (2024) · low 116 (2020)2026

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

Recalls per year · PKC

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · PKC

86in 2025

2017: 12018: 52019: 82020: 52021: 142022: 312023: 462024: 542025: 86
2007high 86 (2025) · low 0 (2007)2025

MAUDE reports naming product code PKC, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20171—01
20181—05
20191—18
2020411605
20212—014
20223148031
20231—046
20243167054
20251—086
20262—0—

What is it indicated for?

The Stemless Shoulder System is comprised of modular humeral fixation components and humeral heads to be used in total shoulder arthroplasty.

The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Stemless humeral components are intended for press-fit fixation without the use of bone cement. The glenoid components are intended only for use with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K171858

4 other devices cite the same predicate.

  • K241873OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
  • K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  • K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
  • K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019

More from Depuy (Ireland)

13 FDA decisions under this applicant name. See the company

  • K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
  • K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019
  • K191779Attune Revision LPS InsertsDepuy (Ireland) · 20194 recalls
  • K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland) · 2019
  • K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland) · 2019

Recent decisions in PKC

The PKC category page

  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc. · 2026
  • K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2025
  • K243248Inhance Intact™Depuy Ireland UC · 2024
  • K241873OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024

https://510kreport.com/device/K212683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212683: GLOBAL ICON Stemless Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212683

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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