510(k) · Cleared
ClearedBiomet Microfixation RibFix Blu 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 Mar 24, 2016 as substantially equivalent to K142823 (Biomet Microfixation, 2015) and 1 other predicate after a 227-day review. Its family tree reaches back 13 generations to 1976. 11 later devices descend from it.
- Decided
- Mar 24, 2016
- Review
- 227 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K761228 (1976). 43 ancestors in all. 11 later devices descend from it, 2 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 backK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- This deviceK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- Descendant · cites it directly · 8 of its ownK162974 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- Descendant · 2 generations on · 4 of its ownK212608 RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2022
- Descendant · 2 generations on · 3 of its ownK190409 MatrixRIB Fixation SystemDePuy Synthes · 2019
- Descendant · cites it directly · 1 of its ownK221412 ARIX Rib SystemJeil Medical Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK261892 ProRib Fixation SystemCosta Surgical, Inc. · 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 backK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- This deviceK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · cites it directly8descendants
- K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2022 · 2 generations on4descendants
- K190409MatrixRIB Fixation SystemDePuy Synthes · 2019 · 2 generations on3descendants
- K221412ARIX Rib SystemJeil Medical Corporation · 2022 · cites it directly1descendant
- K261892ProRib Fixation SystemCosta Surgical, Inc. · 2026 · 3 generations on0descendants
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 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| 0 (this device) | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| +1 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| +2 | K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2022 | — |
| +2 | K190409 | MatrixRIB Fixation System | DePuy Synthes | 2019 | — |
| +1 | K221412 | ARIX Rib System | Jeil Medical Corporation | 2022 | — |
| +3 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K142823 | Biomet Microfixation Thoracic Fixation 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: K142823, Biomet Microfixation Thoracic Fixation System… | 2015 |
| * | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation SystemSummary page 5…: K142823, Biomet Microfixation Thoracic Fixation System K152253 (page 2 of 2) K151173, Biomet Microfixation RibFix Blu Thoracic Fixation System Similarities to Predicate Devices: The predicate and subject devices a… | 2015 |
What descends from it? (11)
See all 112 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 40 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 5 of the 43 ancestors have a recall of any class.
- Of its descendants, K162974 (Biomet Microfixation, 2016) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K142823.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 RibFix Blu 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/K152253 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152253: Biomet Microfixation RibFix Blu Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152253
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