510(k) · Cleared
ClearedKLS-Martin Temporary Condylar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · NEI Prosthesis, Condyle, Mandibular, Temporary
Cleared on Jul 27, 2001 after an 878-day review. The FDA summary names its predicate without a number. 437 later devices descend from it.
- Decided
- Jul 27, 2001
- Review
- 878 days
- Class
- Class II
- Product code
- NEI
- Recalls
- None
- Predicates
- 0
437 later devices descend from it, 3 citing it directly.
- This deviceK990667 KLS-Martin Temporary Condylar ImplantKLS-Martin L.P. · 2001
- Descendant · cites it directly · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- Descendant · 2 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 3 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 4 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Showing 5 of 437 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 437 · See all- K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · cites it directly435descendants
- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 2 generations on360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 3 generations on343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 4 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 5 generations on339descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990667 | KLS-Martin Temporary Condylar Implant | KLS-Martin L.P. | 2001 | — |
| +1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| +2 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 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 NEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Leibinger Temporary Condylar Implant Named without a submission number |
What descends from it? (437)
See all 4373 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?
- Of its descendants, K032442 (KLS-Martin L.P., 2003) has gone furthest, with 435 descendants of its own.
How does its category compare?
All NEI devicesNEI Prosthesis, Condyle, Mandibular, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEI
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NEI
Too few NEI 510(k)s in any year since 2007 to give a median.
Recalls per year · NEI
No recall names NEI since 2007.
Adverse event reports per year · NEI
2in 2024
MAUDE reports naming product code NEI, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
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/K990667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990667: KLS-Martin Temporary Condylar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990667
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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