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 Mar 28, 2023 as substantially equivalent to K972420 (Walter Lorenz Surgical, Inc., 1997) and 1 other predicate after a 270-day review. Its family tree reaches back 13 generations to 1976. 6 later devices descend from it.
- Decided
- Mar 28, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K761228 (1976). 103 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 9 generations between
- 3 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- 2 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- 1 generation backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- This deviceK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
- Descendant · cites it directly · 2 of its ownK243357 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK250892 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK241018 KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024
- Descendant · 2 generations on · 0 of its ownK260448 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253660 KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2026
Show all 13 generations
- Root · 13 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 12 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 11 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 10 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 9 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 8 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 7 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 6 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 5 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 4 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 3 generations backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- 2 generations backK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- 1 generation backK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- This deviceK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · cites it directly2descendants
- K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · 2 generations on1descendant
- K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P. · 2024 · cites it directly1descendant
- K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
- K253660KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −12 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −11 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −10 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −9 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −8 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −7 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −6 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −5 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −4 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −3 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| −2 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| −1 | K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016 | — |
| 0 (this device) | K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023 | — |
| +1 | K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
| +2 | K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
| +1 | K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | 2024 | — |
| +2 | K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026 | — |
| +1 | K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 10 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K972420 | Lorenz Pectus Support BarSummary page 4…ber 888.3030 Product Code HRS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K972420 Lorenz Pectus Support Bar HRS K153482 KLS Martin Thoracic Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) The… | 1997 |
| * | K153482 | KLS Martin Thoracic Plating SystemSummary page 4…ly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K972420 Lorenz Pectus Support Bar HRS K153482 KLS Martin Thoracic Plating System HRS Device Description Summary 21 CFR 807.92(a)(4) The KLS Martin LP Pure Pectus system consi… | 2016 |
What descends from it? (6)
4 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 47 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 103 ancestors have a recall of any class.
- Of its descendants, K243357 (L&K BIOMED Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K972420.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K221938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221938: 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/K221938
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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