510(k) · Cleared
ClearedKLS Martin Hand Plating 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 13, 2004 as substantially equivalent to K961497 (Howmedica, Inc., 1996) and 5 other predicates after a 66-day review. Its family tree reaches back 4 generations to 1996. 360 later devices descend from it.
- Decided
- May 13, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K954385 (1996). 17 ancestors in all, the oldest K943347 (1994). 360 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 3 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 2 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 1 generation backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- This deviceK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 2 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · 3 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 3 generations on · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
Showing 5 of 360 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 360 · See all- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · cites it directly343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 2 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 3 generations on339descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 3 generations on228descendants
- K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · 3 generations on119descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −3 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −2 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| 0 (this device) | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +1 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +2 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +3 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +3 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 14 | 0 |
| 2013 | 8 | 0 |
| 2014 | 16 | 0 |
| 2015 | 25 | 0 |
| 2016 | 14 | 0 |
| 2017 | 31 | 0 |
| 2018 | 16 | 0 |
| 2019 | 19 | 0 |
| 2020 | 28 | 0 |
| 2021 | 24 | 0 |
| 2022 | 24 | 0 |
| 2023 | 29 | 0 |
| 2024 | 41 | 0 |
| 2025 | 25 | 0 |
| 2026 | 38 | 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? (6)
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 |
|---|---|---|---|
| * | K961497 | Profyle Titanium Hand and Small Fragment SystemSummary page 1…Appliances and Accessories (CFR 888.3030) Regulatory Class: Class II Predicate Devices: ProfyleTM Titanium Hand and Small Fragment System (K961497) Lorenz Small Fragment System (K992961) Normed Extremity Titanium Hand a… | 1996 |
| * | K992961 | Lorenz Small Fragment SystemSummary page 1…s: Class II Predicate Devices: ProfyleTM Titanium Hand and Small Fragment System (K961497) Lorenz Small Fragment System (K992961) Normed Extremity Titanium Hand and Small Fragment System (KO0 1118)… | 1999 |
| * | K011118 | Normed Extremity Titanium Hand and Small Fragment System Our reading of the summary gave K001118, FDA’s number for Modification to Lipoprotein (a) SPQ Iii Antibody Reagent Set (DiaSorin, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Normed Extremity Titanium Hand and Small Fragment System”. | 2001 |
| * | K032442 | KLS-Martin Mandibular/Reconstruction System IISummary page 1…d Small Fragment System (KO0 1118) KLS Martin Mandibular Fracture/Reconstruction System II (K032442) KLS-Martin Micro Osteosythesis System(1.5mm) (K944565)… | 2003 |
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…Fracture/Reconstruction System II (K032442) KLS-Martin Micro Osteosythesis System(1.5mm) (K944565) Micro Osteosynthesis System (1.Omm)(K944561) Device Description: The KLS Martin Hand Plating Syste… | 1994 |
| * | K944561 | Micro Osteosynthesis System (1.0)Summary page 1…42) KLS-Martin Micro Osteosythesis System(1.5mm) (K944565) Micro Osteosynthesis System (1.Omm)(K944561) Device Description: The KLS Martin Hand Plating System consists of plates of various lengths and th… | 1994 |
What descends from it? (360)
See all 3605 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 8 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K050868 (Orthohelix Surgical Designs, Inc., 2005) has gone furthest, with 343 descendants of its own.
- 8 other devices also cite its predicate K961497.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040598: KLS Martin Hand Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040598
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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