510(k) · Cleared
ClearedPectus Blu Support Bar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · HRS Plate, Fixation, Bone
Cleared on Sep 19, 2024 as substantially equivalent to K212841 (Biomet Micofixation, 2022) after a 98-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 19, 2024
- Review
- 98 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972420 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- 3 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- 2 generations backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- 1 generation backK212841 Pectus Blu Support Bar SystemBiomet Micofixation · 2022
- This deviceK241709 Pectus Blu Support Bar SystemBiomet Microfixation · 2024
- 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 · 0 of its ownK261002 Pectus Blu SystemBiomet Microfixation · 2026
- Descendant · 2 generations on · 0 of its ownK260448 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · 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
- K261002Pectus Blu SystemBiomet Microfixation · 2026 · cites it directly0descendants
- K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| −3 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| −2 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| −1 | K212841 | Pectus Blu Support Bar System | Biomet Micofixation | 2022 | — |
| 0 (this device) | K241709 | Pectus Blu Support Bar System | Biomet Microfixation | 2024 | — |
| +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 | K261002 | Pectus Blu System | Biomet Microfixation | 2026 | — |
| +2 | K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K212841 | Pectus Blu Support Bar SystemSummary page 5…lass II Product Code: HRS Regulation Number and Description: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories 510(K) Numbers: K212841 The similarities of the subject devices to the predicate devices are as follows: • Indications for Use/Intended use • Supp… | 2022 |
What descends from it? (4)
2 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 27 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K243357 (L&K BIOMED Co., Ltd., 2025) has gone furthest, with 2 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. 2024, 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 Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal
deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241709 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241709: Pectus Blu Support Bar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241709
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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