510(k) · Cleared
ClearedKLS Martin Ixos System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS Martin L.P. · HRS Plate, Fixation, Bone
Cleared on Feb 20, 2026 as substantially equivalent to K222624 (KLS-Martin L.P., 2023) and 2 other predicates after a 60-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Feb 20, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K000684 (2000). 62 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations between
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 1 generation backK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
- This deviceK254162 KLS Martin Ixos SystemKLS Martin L.P. · 2026
Show all 10 generations
- Root · 10 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 9 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 8 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 7 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 6 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 5 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 4 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 3 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 2 generations backK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
- 1 generation backK143749 Arthrex Distal Radius SystemArthrex, Inc. · 2015
- This deviceK254162 KLS Martin Ixos SystemKLS Martin L.P. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −9 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −8 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −7 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −6 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −5 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −4 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −2 | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
| −1 | K143749 | Arthrex Distal Radius System | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 9 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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? (3)
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 |
|---|---|---|---|
| * | K222624 | KLS Martin LINOS Wrist SystemSummary page 6…mplants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624). The purpose of this premarket notification is to expand the lxos system to include anatomically pre-contoured plates designed… | 2023 |
| * | K143749 | Arthrex Distal Radius System | 2015 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 5…Distal Radius System I~ _ _ _~ I H_R_S I K092247 1 1 Synthes Locking Hand Plates 1 1 HRS Device Description Summary… | 2009 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 62 ancestors have a recall of any class.
- 3 other devices also cite its predicate K222624.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The KLS Martin lxos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254162: KLS Martin Ixos System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254162
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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