510(k) · Cleared
ClearedLorenz Pectus Support Bar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 11, 1997 after a 45-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.
- Decided
- Aug 11, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 5 citing it directly.
- This deviceK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- Descendant · cites it directly · 42 of its ownK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- Descendant · cites it directly · 41 of its ownK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- Descendant · cites it directly · 32 of its ownK073556 Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008
- Descendant · 2 generations on · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
- Descendant · 3 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K981789Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998 · cites it directly42descendants
- K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006 · cites it directly41descendants
- K073556Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosMedxpert GmbH · 2008 · cites it directly32descendants
- K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · 2 generations on26descendants
- K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| +1 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| +1 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| +1 | K073556 | Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos | Medxpert GmbH | 2008 | — |
| +2 | K133616 | Matrixrib Fixation System | Synthes (USA) Products, LLC | 2014 | — |
| +3 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | — | Adkins Strut Named without a submission number | |
| * | — | Strib Named without a submission number |
What descends from it? (43)
See all 435 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981789 | Lorenz Pectus Support Bar Stabilizer | 1998 | 42 |
| K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium | 2006 | 41 |
| K073556 | Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos | 2008 | 32 |
| K221938 | KLS Martin Pure Pectus System | 2023 | 6 |
| K071577 | Biomet Microfixation Lactosorb Pectus Stabilizer | 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?
- Of its descendants, K981789 (Walter Lorenz Surgical, Inc., 1998) has gone furthest, with 42 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This devics is intended for use in surgical procedures to regair Pectus Excavatum an< other sternal deformities.
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/K972420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972420: Lorenz Pectus Support Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972420
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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