510(k) · Cleared
ClearedAlliance Augmented Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Feb 24, 2020 as substantially equivalent to K191814 (Zimmer, Inc., 2019) after a 98-day review. Its family tree reaches back 6 generations to 1980. 3 later devices descend from it.
- Decided
- Feb 24, 2020
- Review
- 98 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K800494 (1980). 28 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 4 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 3 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- 2 generations backK060694 Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · Recalled
- 1 generation backK191814 Alliance GlenoidZimmer, Inc. · 2019
- This deviceK193180 Alliance Augmented GlenoidZimmer, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK233148 Augment Off-Axis Instrument SystemFix Surgical · 2024
- Descendant · 2 generations on · 1 of its ownK241043 Augment Off-Axis Instrument SystemFix Surgical · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK261683 Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −5 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −4 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −3 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| −2 | K060694 | Modular Hybrid Glenoid | Biomet Manufacturing Corp | 2006 | 4 |
| −1 | K191814 | Alliance Glenoid | Zimmer, Inc. | 2019 | — |
| 0 (this device) | K193180 | Alliance Augmented Glenoid | Zimmer, Inc. | 2020 | — |
| +1 | K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024 | — |
| +2 | K241043 | Augment Off-Axis Instrument System | Fix Surgical | 2024 | 5 |
| +3 | K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 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.
Planning a device in KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233148 | Augment Off-Axis Instrument System | 2024 | 2 |
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 40 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 10 of the 28 ancestors have a recall of any class.
- Of its descendants, K233148 (Fix Surgical, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and…
Read the full statement (114 words)
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193180: Alliance Augmented Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193180
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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