510(k) · Cleared
ClearedAugmented VaultLock Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 7, 2021 as substantially equivalent to K161108 (Arthrex, Inc., 2016) after a 150-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 7, 2021
- Review
- 150 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010124 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK010124 Arthrex Univers 30 Shoulder ProsthesisArthrex, Inc. · 2001
- 4 generations backK071032 Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2007
- 3 generations backK083435 Arthrex Univers II Shoulder Pegged GlenoidArthrex, Inc. · 2009
- 2 generations backK120044 Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL…Arthrex, Inc. · 2012
- 1 generation backK161108 Arthrex VaultLock GlenoidArthrex, Inc. · 2016
- This deviceK210050 Augmented VaultLock GlenoidArthrex, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010124 | Arthrex Univers 30 Shoulder Prosthesis | Arthrex, Inc. | 2001 | — |
| −4 | K071032 | Arthrex Univers II Shoulder Prosthesis | Arthrex, Inc. | 2007 | — |
| −3 | K083435 | Arthrex Univers II Shoulder Pegged Glenoid | Arthrex, Inc. | 2009 | — |
| −2 | K120044 | Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled | Arthrex, Inc. | 2012 | — |
| −1 | K161108 | Arthrex VaultLock Glenoid | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K210050 | Augmented VaultLock Glenoid | Arthrex, Inc. | 2021 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161108 | Arthrex VaultLock GlenoidSummary page 4…KWS Classification Name 21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented Regulatory Class II Predicate Device K161108: Arthrex VaultLock Glenoid Reference Device K191960: Arthrex Univers Revers Modular Glenoid System… | 2016 |
| † | K191960 | Arthrex Univers Revers Modular Glenoid System | 2019 |
| † | K071032 | Arthrex Univers II Shoulder Prosthesis | 2007 |
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 20 years and passes through 1 company; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K161108.
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. 2021, 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?
The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with appropriate bone cement.
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/K210050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210050: Augmented VaultLock Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210050
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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