510(k) · Cleared
ClearedKlsa Martin Hand Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · JEC Component, Traction, Invasive
Cleared on Aug 25, 2004 as substantially equivalent to K973275 (KLS-Martin L.P., 1997) and 3 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Aug 25, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K792561 (1979). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 2 generations backK973275 KLS-Martin Intraoral DistractorKLS-Martin L.P. · 1997
- 1 generation backK983515 KLS Intraoral Vertical DistractorKLS-Martin L.P. · 1998
- This deviceK042066 Klsa Martin Hand DistractorKLS-Martin L.P. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −3 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −2 | K973275 | KLS-Martin Intraoral Distractor | KLS-Martin L.P. | 1997 | — |
| −1 | K983515 | KLS Intraoral Vertical Distractor | KLS-Martin L.P. | 1998 | — |
| 0 (this device) | K042066 | Klsa Martin Hand Distractor | KLS-Martin L.P. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K973275 | KLS-Martin Intraoral DistractorSummary page 1…readed metallic bone fixation fastener (CFR 888.3040) Regulatory Class: Class II Predicate Devices: KLS-Martin Intraoral Distractor (K973275) KLS-Martin Intra-Oral Mandibular Distractor (K983515)… | 1997 |
| * | K983515 | KLS Intraoral Vertical DistractorSummary page 1…Class II Predicate Devices: KLS-Martin Intraoral Distractor (K973275) KLS-Martin Intra-Oral Mandibular Distractor (K983515) Hoffmann II Compact External Fixation System (K971755)… | 1998 |
| * | K971755 | Hoffmann II Compact External Fixation SystemSummary page 1…artin Intra-Oral Mandibular Distractor (K983515) Hoffmann II Compact External Fixation System (K971755) Acumed Stableloc II External Fixation System (K965029) Intended Use:… | 1997 |
| * | K965029 | Stableloc II External FixatorSummary page 1…n II Compact External Fixation System (K971755) Acumed Stableloc II External Fixation System (K965029) Intended Use: The KLS Martin Hand Distractor is designed to be used in finger reconstructio… | 1997 |
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 25 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 4 other devices also cite its predicate K973275.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones I - IVafter amputation or malformation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042066: Klsa Martin Hand Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042066
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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