510(k) · Cleared
ClearedBiomet Microfixation Thoracic Fixation 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 Feb 25, 2015 as substantially equivalent to K121302 (Biomet Microfixation, 2012) and 1 other predicate after a 148-day review. Its family tree reaches back 11 generations to 1976. 23 later devices descend from it.
- Decided
- Feb 25, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K761228 (1976). 41 ancestors in all. 23 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations between
- 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- This deviceK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- Descendant · cites it directly · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- Descendant · cites it directly · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- Descendant · cites it directly · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- Descendant · 2 generations on · 8 of its ownK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- Descendant · 2 generations on · 6 of its ownK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
Show all 11 generations
- Root · 11 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 10 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 9 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 8 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 7 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 6 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 5 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 4 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 3 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 2 generations backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- 1 generation backK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- This deviceK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · cites it directly13descendants
- K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · cites it directly11descendants
- K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · cites it directly9descendants
- K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 2 generations on8descendants
- K221938KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −10 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −9 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −7 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −6 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −5 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −4 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −3 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −2 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| −1 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| 0 (this device) | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| +1 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| +1 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| +1 | K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016 | — |
| +2 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| +2 | K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K121302 | Biomet Microfixation Sternal Closure SystemSummary page 4…es of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V). Predicate Devices: K121302, Biomet Microfixation Sternal Closure System K133616, Synthes MatrixRIB Plating System… | 2012 |
| * | K133616 | Matrixrib Fixation SystemSummary page 4…multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V). Predicate Devices: K121302, Biomet Microfixation Sternal Closure System K133616, Synthes MatrixRIB Plating System K14… | 2014 |
What descends from it? (23)
See all 234 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 39 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 41 ancestors have a recall of any class.
- Of its descendants, K151173 (Biomet Microfixation, 2015) has gone furthest, with 13 descendants of its own.
- 7 other devices also cite its predicate K121302.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142823: Biomet Microfixation Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142823
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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