510(k) · Cleared
ClearedIgnite Stemless Anatomic Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ignite Orthopedics, LLC · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Jul 16, 2021 as substantially equivalent to K171858 (Zimmer GmbH, 2017) and 7 other predicates after a 274-day review. Its family tree reaches back 15 generations to 1991. 1 of the 182 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 16, 2021
- Review
- 274 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 15 generations to K911686 (1991). 178 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 3 citing it directly. 1 of the 182 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 backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- This deviceK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · cites it directly · 0 of its ownK243248 Inhance Intact™Depuy Ireland UC · 2024
- Descendant · cites it directly · 0 of its ownK230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE…Depuy Ireland UC · 2023
- Descendant · cites it directly · 0 of its ownK223211 INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022
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 backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- This deviceK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K243248Inhance Intact™Depuy Ireland UC · 2024 · cites it directly0descendants
- K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC · 2023 · cites it directly0descendants
- K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022 · cites it directly0descendants
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 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −1 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| 0 (this device) | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +1 | K243248 | Inhance Intact™ | Depuy Ireland UC | 2024 | — |
| +1 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023 | — |
| +1 | K223211 | INHANCETM Shoulder System – Humeral Stems and Stemless | Depuy Ireland UC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171858 | Sidus Stem-Free ShoulderSummary page 4…is, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (21 CER §888.3660); Class II Product Codes: PKC, PAO Predicate Devices: K171858 (Primary), Sidus Stem-Free Shoulder, Zimmer GmbH K202716, Ignite Anatomic Shoulder System, Ignite Orthopedic… | 2017 |
| * | K202716 | Ignite Anatomic Shoulder System Cleared while this submission was under review Summary page 4…Cemented (21 CER §888.3660); Class II Product Codes: PKC, PAO Predicate Devices: K171858 (Primary), Sidus Stem-Free Shoulder, Zimmer GmbH K202716, Ignite Anatomic Shoulder System, Ignite Orthopedics LLC K143552, Simpliciti Shoulder System, Tornier, Inc.… | 2021 |
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…es: K171858 (Primary), Sidus Stem-Free Shoulder, Zimmer GmbH K202716, Ignite Anatomic Shoulder System, Ignite Orthopedics LLC K143552, Simpliciti Shoulder System, Tornier, Inc. K182516, Comprehensive Nano Stemless Shoulder, Biomet… | 2015 |
| * | K182516 | Comprehensive Nano Stemless ShoulderSummary page 4…K202716, Ignite Anatomic Shoulder System, Ignite Orthopedics LLC K143552, Simpliciti Shoulder System, Tornier, Inc. K182516, Comprehensive Nano Stemless Shoulder, Biomet Manufacturing Corp K183194, Arthrex Eclip… | 2019 |
| * | K183194 | Arthrex Eclipse Shoulder Prosthesis SystemSummary page 4…ti Shoulder System, Tornier, Inc. K182516, Comprehensive Nano Stemless Shoulder, Biomet Manufacturing Corp K183194, Arthrex Eclipse Shoulder Prosthesis System K173388, Exactech Equinoxe Stemless Shoulder, Exactech Inc… | 2019 |
| * | K173388 | Exactech Equinoxe Stemless ShoulderSummary page 4…sive Nano Stemless Shoulder, Biomet Manufacturing Corp K183194, Arthrex Eclipse Shoulder Prosthesis System K173388, Exactech Equinoxe Stemless Shoulder, Exactech Inc K193226, AltiVate Anatomic Canal-Sparing (CS) Shoulder, E… | 2018 |
| * | K193226 | AltiVate Anatomic Canal-Sparing (CS) ShoulderSummary page 4…K183194, Arthrex Eclipse Shoulder Prosthesis System K173388, Exactech Equinoxe Stemless Shoulder, Exactech Inc K193226, AltiVate Anatomic Canal-Sparing (CS) Shoulder, Encore Medical, L.P K083439, Synthes Ep… | 2020 |
| * | K083439 | Synthes Epoca Shoulder Prosthesis SystemSummary page 4…temless Shoulder, Exactech Inc K193226, AltiVate Anatomic Canal-Sparing (CS) Shoulder, Encore Medical, L.P K083439, Synthes Epoca Shoulder Prosthesis System, Synthes (USA)… | 2009 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 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 9 companies; a new generation was cleared every 9 months on median.
- 49 of the 178 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243248 (Depuy Ireland UC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K171858.
How does its category compare?
All PKC devicesPKC 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. 2021, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:
* Osteoarthritis;
» Posttraumatic arthrosis;
» Focal avascular necrosis of the humeral head;
* Previous surgeries of the shoulder that do not compromise the fixation.
Fixation Methods
The stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
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/K203108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203108: Ignite Stemless Anatomic 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/K203108
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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