510(k) · Cleared
ClearedArthrex Fracture Adapter Hemi Shoulder Prosthesis
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 Dec 21, 2018 as substantially equivalent to K020345 (Arthrex, Inc., 2002) and 3 other predicates after a 191-day review. Its family tree reaches back 13 generations to 1991. 1 later device descends from it.
- Decided
- Dec 21, 2018
- Review
- 191 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K911686 (1991). 47 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 2 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 1 generation backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- This deviceK181555 Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 6 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 5 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 4 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 3 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 2 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 1 generation backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- This deviceK181555 Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −6 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −5 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −4 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −3 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −2 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −1 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | Arthrex, Inc. | 2018 | — |
| +1 | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K020345 | Arthrex Univers Fracture ProsthesisSummary page 4…21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class II Predicate Device K020345: Arthrex Univers Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis… | 2002 |
| * | K071032 | Arthrex Univers II Shoulder ProsthesisSummary page 4…r) metallic uncemented prosthesis Regulatory Class II Predicate Device K020345: Arthrex Univers Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System… | 2007 |
| * | K130129 | Univers Revers Shoulder Prosthesis SystemSummary page 4…ss II Predicate Device K020345: Arthrex Univers Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System Purpose of This Traditional 510(k) premarket notification i… | 2013 |
| * | K142863 | Univers Rivers Shoulder Prosthesis SystemSummary page 4…II Predicate Device K020345: Arthrex Univers Fracture Prosthesis K071032: Arthrex Univers II Shoulder Prosthesis K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System Purpose of This Traditional 510(k) premarket notification is submit… | 2014 |
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 |
|---|---|---|---|
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | 2023 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 47 ancestors have a recall of any class.
- Of its descendants, K230366 (Arthrex, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020345.
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. 2018, 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 Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures…
Read the full statement (105 words)
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or-4-fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck.
The Arthrex Fracture Adapter Hemi Shoulder Prosthesis is for uncemented use. The device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181555
Report an extraction error
Are you the manufacturer?
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