510(k) · Cleared
ClearedKLS Martin LINOS Wrist 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 May 25, 2023 as substantially equivalent to K142906 (Medartis AG, 2015) after a 267-day review. Its family tree reaches back 7 generations to 1996. 5 later devices descend from it.
- Decided
- May 25, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962616 (1996). 21 ancestors in all, the oldest K885250 (1989). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 2 generations backK103332 Aptus Ulna PlatesMedartis AG · 2011
- 1 generation backK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- This deviceK222624 KLS Martin LINOS Wrist SystemKLS-Martin L.P. · 2023
- Descendant · cites it directly · 1 of its ownK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
- Descendant · cites it directly · 0 of its ownK254162 KLS Martin Ixos SystemKLS Martin L.P. · 2026
- Descendant · 2 generations on · 0 of its ownK250988 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
- Descendant · cites it directly · 0 of its ownK250865 KLS Martin IPS Forearm SystemKLS-Martin L.P. · 2025
- Descendant · cites it directly · 0 of its ownK250620 KLS Martin Ixos SystemKLS Martin L.P. · 2025
Most influential descendants
Showing 5 of 5 · See all- K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024 · cites it directly1descendant
- K254162KLS Martin Ixos SystemKLS Martin L.P. · 2026 · cites it directly0descendants
- K250988KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025 · 2 generations on0descendants
- K250865KLS Martin IPS Forearm SystemKLS-Martin L.P. · 2025 · cites it directly0descendants
- K250620KLS Martin Ixos SystemKLS Martin L.P. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −2 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| −1 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| 0 (this device) | K222624 | KLS Martin LINOS Wrist System | KLS-Martin L.P. | 2023 | — |
| +1 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024 | — |
| +1 | K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026 | — |
| +2 | K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025 | — |
| +1 | K250865 | KLS Martin IPS Forearm System | KLS-Martin L.P. | 2025 | — |
| +1 | K250620 | KLS Martin Ixos System | KLS Martin L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 5…ation. Indications for Use Comparison 21 CFR 807.92(a)(5) The intended use of the subject device is identical to the primary predicate device, APTUS® Wrist 2.5 System (K142906). The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verifi… | 2015 |
| † | K171624 | IXOS Radius Plate System | 2018 |
| † | K170124 | Level One Hand Plating System | 2017 |
| † | K110125 | 2.4 MM VA-LCP Volar Rim Distal Radius System | 2011 |
| † | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | 2019 |
| † | K191972 | ARIX Wrist System | 2019 |
What descends from it? (5)
4 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 27 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K241018 (KLS-Martin L.P., 2024) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K142906.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 LINOS Wrist System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.
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/K222624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222624: KLS Martin LINOS Wrist System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222624
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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