510(k) · Cleared
ClearedKLS-Martin Mandibular/Reconstruction System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Oct 29, 2003 as substantially equivalent to K961421 (Synthes (Usa), 1996) and 5 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1996. 435 later devices descend from it.
- Decided
- Oct 29, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K954385 (1996). 11 ancestors in all, the oldest K943347 (1994). 435 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 2 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 1 generation backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- This deviceK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- Descendant · cites it directly · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 2 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 3 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
Showing 5 of 435 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 435 · See all- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · cites it directly360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 2 generations on343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 3 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 4 generations on339descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −2 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −1 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| 0 (this device) | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| +1 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +2 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +3 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| +4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 15 | 0 |
| 2013 | 9 | 0 |
| 2014 | 18 | 0 |
| 2015 | 26 | 0 |
| 2016 | 16 | 0 |
| 2017 | 32 | 0 |
| 2018 | 17 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 28 | 0 |
| 2022 | 29 | 0 |
| 2023 | 38 | 0 |
| 2024 | 54 | 0 |
| 2025 | 39 | 0 |
| 2026 | 51 | 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 MQN? 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 MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K961421 | Synthes 2.4 MM Universal Locking Plate SystemSummary page 1…Plate, Bone (CFR 872.4760) Regulatory CIass : Class I1 Predicate Devices: Synthes Universal 2.4mm Locking Plate System (K961421) Synthes 2.0 Locking Plate System (K974555) KLS-Mart… | 1996 |
| * | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS)Summary page 1…Synthes Universal 2.4mm Locking Plate System (K961421) Synthes 2.0 Locking Plate System (K974555) KLS-Martin Mandibular / Reconstruction System (K950045)… | 1998 |
| * | K950045 | KLS-Martin Mandibular Fracture/Reconstruction SystemSummary page 1…Synthes 2.0 Locking Plate System (K974555) KLS-Martin Mandibular / Reconstruction System (K950045) KLS Mini Osteosynthesis System (K943347) OSTEOMED 2… | 1995 |
| * | K943347 | KLS Mini Osteosynthesis SystemSummary page 1…KLS-Martin Mandibular / Reconstruction System (K950045) KLS Mini Osteosynthesis System (K943347) OSTEOMED 2.0 Locking Plates and Screws (KO30448) KL… | 1994 |
| * | K030448 | Osteomed 2.0 Locking Plates and ScrewsSummary page 2…ion System (K950045), KLS Mini Osteosynthesis System (K943347), OSTEOMED 2.0 Locking Plates and Screws (K030448), and KLS-Martin Temporary Condylar Implant (K990667). Screws… | 2003 |
| * | K990667 | KLS-Martin Temporary Condylar ImplantSummary page 1…OSTEOMED 2.0 Locking Plates and Screws (KO30448) KLS-Martin Temporary Condylar Implant (K990667) c-I P.O.Box 50249 Jacksonville, FL 32250-02… | 2001 |
What descends from it? (435)
See all 4357 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040598 | KLS Martin Hand Plating System | 2004 | 360 |
| K060177 | KLS Martin Rigid Fixation - Sterile | 2006 | 65 |
| K163579 | KLS Martin Individual Patient Solutions | 2017 | 9 |
| K080694 | Osteomed Modular Locking Fixation System | 2008 | 2 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | 2024 | 1 |
| K180962 | KLS Martin Individual Patient Solutions | 2018 | 0 |
| K071612 | Modus Trilock 2.0/2.3/2.5 | 2007 | 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 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K040598 (KLS-Martin L.P., 2004) has gone furthest, with 360 descendants of its own.
- 5 other devices also cite its predicate K961421.
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, 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 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KLS Martin Mandibular / Reconstruction System I I is intended for use in the stabilization and fixation ,of mandibular fractures and mandibular reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032442: KLS-Martin Mandibular/Reconstruction System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032442
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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