510(k) · Cleared
ClearedShoulder Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Innovations, LLC · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Feb 27, 2006 as substantially equivalent to K051728 (Hand Innovations, LLC, 2005) after a 21-day review. Its family tree reaches back 2 generations to 2004. 25 later devices descend from it.
- Decided
- Feb 27, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042059 (2004). 25 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
- 1 generation backK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
- This deviceK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
- Descendant · cites it directly · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · cites it directly17descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042059 | Shoulder Fixation System | Hand Innovations, Inc. | 2004 | — |
| −1 | K051728 | Modification to Shoulder Fixation System | Hand Innovations, LLC | 2005 | — |
| 0 (this device) | K060290 | Shoulder Fixation System | Hand Innovations, LLC | 2006 | — |
| +1 | K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing | 2015 | 18 |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K051728 | Modification to Shoulder Fixation SystemSummary page 1…em Plate Fixation Bone Name of The device is substantially equivalent to: Predicate * Shoulder Fixation System (510(k) # K051728 - July 20, 2005) - Hand Devices Innovations, LLC. Classification Class II. Performan… | 2005 |
What descends from it? (25)
See all 254 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143697 (Biomet Manufacturing, 2015) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K051728.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Modified Shoulder Fixation System is intended for fractures and fracture dislocations,
osteotomies, and non-unions of the proximal Humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060290: Shoulder Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060290
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