510(k) · Cleared
ClearedKLS Martin Pure Pectus 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 Dec 11, 2025 as substantially equivalent to K221938 (KLS Martin L.P., 2023) and 1 other predicate after a 255-day review. Its family tree reaches back 15 generations to 1976.
- Decided
- Dec 11, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K761228 (1976). 137 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 11 generations between
- 3 generations backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- 2 generations backK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
- 1 generation backK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
- This deviceK250988 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
Show all 15 generations
- Root · 15 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 14 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 13 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 12 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 11 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 10 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 9 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 8 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 7 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 6 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 5 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- 4 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- 3 generations backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- 2 generations backK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
- 1 generation backK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
- This deviceK250988 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −14 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −13 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −12 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −11 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −10 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −9 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −8 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −7 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −6 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −5 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| −4 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −3 | K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016 | — |
| −2 | K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023 | — |
| −1 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024 | — |
| 0 (this device) | K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 10 | 0 |
| 1995 | 5 | 0 |
| 1996 | 14 | 0 |
| 1997 | 6 | 0 |
| 1998 | 14 | 0 |
| 1999 | 6 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 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? (2)
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 |
|---|---|---|---|
| * | K221938 | KLS Martin Pure Pectus SystemSummary page 6…cate. Both devices are manufactured from titanium, a well- known biocompatible material. Target Population: The subject device, as well as the primary predicate device, K221938, were cleared for use in the adult and pediatric populations, specifically in the following pediatric subpopulations: - Children… | 2023 |
| * | K241018 | KLS Martin Orthopedic Implants - MR Conditional | 2024 |
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 49 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 15 of the 137 ancestors have a recall of any class.
- 3 other devices also cite its predicate K221938.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum.
It is indicated for use in adult and pediatric (children and adolescents) populations.
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/K250988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250988: KLS Martin Pure Pectus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250988
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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