510(k) · Cleared
ClearedINHANCETM Hybrid Anatomic Glenoid Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jun 8, 2022 as substantially equivalent to K202716 (Ignite Orthopedics, LLC, 2021) and 1 other predicate after a 266-day review. Its family tree reaches back 15 generations to 1991. 1 of the 162 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 8, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K911686 (1991). 160 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 162 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 deviceK212933 INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC · 2022
- Descendant · cites it directly · 0 of its ownK243248 Inhance Intact™Depuy Ireland UC · 2024
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 deviceK212933 INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K243248Inhance Intact™Depuy Ireland UC · 2024 · 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) | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | 2022 | — |
| +1 | K243248 | Inhance Intact™ | Depuy Ireland UC | 2024 | — |
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 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 9 | 0 |
| 2006 | 11 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K202716 | Ignite Anatomic Shoulder SystemSummary page 4…sis, Shoulder, Hemi-, Humeral, Metallic Uncemented (21 CER §888.3690); Class II Product Codes: MBF, KWT, KWS, PAO, HSD Predicate Devices: K202716 - Ignite Anatomic Shoulder System; Ignite Orthopedics LLC K060694 - Modular Hybrid Glenoid, Biomet Manufactu… | 2021 |
| * | K060694 | Modular Hybrid GlenoidSummary page 4…90); Class II Product Codes: MBF, KWT, KWS, PAO, HSD Predicate Devices: K202716 - Ignite Anatomic Shoulder System; Ignite Orthopedics LLC K060694 - Modular Hybrid Glenoid, Biomet Manufacturing Corp.… | 2006 |
| † | K052472 | Depuy Global Shoulder Crosslink Glenoid | 2005 |
| † | K212737 | INHANCE™ Reverse Shoulder System | 2022 |
| † | K203108 | Ignite Stemless Anatomic Shoulder System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243248 | Inhance Intact™ | 2024 | 0 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 46 of the 160 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 K202716.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: * Osteoarthritis * Post-traumatic arthrosis * Focal avascular necrosis of the humeral head * Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or…
Read the full statement (170 words)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
* Osteoarthritis
* Post-traumatic arthrosis
* Focal avascular necrosis of the humeral head
* Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
* Revision where other devices or treatments have failed.
* Correction of functional deformity.
* Fractures of the humeral head (with Short Humeral Stems)
* Fractures of the proximal humerus (with Standard or Long Stems)
* Difficult clinical management problems where other methods oftreatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212933: INHANCETM Hybrid Anatomic Glenoid Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212933
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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