510(k) · Cleared
Recalled · 2011Biomet Microfixation Sternalock Blu Sternal Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation, Inc. · HRS Plate, Fixation, Bone
Cleared on May 18, 2011 as substantially equivalent to K033740 (Walter Lorenz Surgical, Inc., 2003) and 1 other predicate after a 78-day review. Its family tree reaches back 8 generations to 1976. 84 later devices descend from it. It has been recalled once.
- Decided
- May 18, 2011
- Review
- 78 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K761228 (1976). 21 ancestors in all. 84 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 6 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 5 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 4 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 3 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 2 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 1 generation backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- This deviceK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- Descendant · cites it directly · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- Descendant · cites it directly · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- Descendant · cites it directly · 46 of its ownK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · cites it directly · 45 of its ownK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
- Descendant · cites it directly · 44 of its ownK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly78descendants
- K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · cites it directly75descendants
- K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly46descendants
- K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · cites it directly45descendants
- K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · cites it directly44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −7 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −4 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −3 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −2 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −1 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| 0 (this device) | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +1 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +1 | K122293 | Pioneer Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +1 | K133785 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| +1 | K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 0 |
| 2026 | 13 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010746 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K033740 | Lorenz Sternal Closure SystemSummary page 2…includes screws with longer lengths that lock into KOl 11076 Design system plates to stabilize and K033740 fixate fr-actures of the anterior K063506 chest wall.… | 2003 |
| * | K063506 | Lorenz Sternal Closure SystemSummary page 2…k into KOl 11076 Design system plates to stabilize and K033740 fixate fr-actures of the anterior K063506 chest wall. MateialPlates: TI Grade IV K0110746… | 2006 |
What descends from it? (84)
See all 848 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111908 | Biomet Microfixation Sternal Closure System | 2011 | 78 |
| K121302 | Biomet Microfixation Sternal Closure System | 2012 | 75 |
| K122293 | Pioneer Sternal Cable Plate System | 2012 | 46 |
| K133785 | Tritium Sternal Cable Plate System | 2014 | 45 |
| K150581 | Tritium Sternal Cable Plate System | 2015 | 44 |
| K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | 2021 | 39 |
| K142484 | Sternal Closure System | 2014 | 1 |
| K181806 | ARIX Sternal System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2011 | Not classified | Z-0843-2012 | Device Design | Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K111908 (Biomet Microfixation, Inc., 2011) has gone furthest, with 78 descendants of its own.
- 4 other devices also cite its predicate K033740.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Biomet Microfixation SternaLock Blu Sternal Closure System is intended for use in the
stabilization and fixation of fractures of the anterior chest wall including Sternal fixation
following Sternotomy and Sternal reconstructive surgical procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110574: Biomet Microfixation Sternalock Blu Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110574
Report an extraction error
Are you the manufacturer?
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