510(k) · Cleared
ClearedBiomet Microfixation Sternal Closure 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, 2012 as substantially equivalent to K011076 (Walter Lorenz Surgical, Inc., 2001) and 2 other predicates after a 141-day review. Its family tree reaches back 10 generations to 1976. 75 later devices descend from it.
- Decided
- Sep 19, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K761228 (1976). 27 ancestors in all. 75 later devices descend from it, 8 citing it directly.
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations between
- 3 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 2 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 1 generation backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- This deviceK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- Descendant · cites it directly · 43 of its ownK151019 SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015
- Descendant · 2 generations on · 40 of its ownK163007 Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016
- Descendant · cites it directly · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 2 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 10 generations
- Root · 10 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 9 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 8 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 7 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 6 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 5 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 4 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 3 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 2 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- 1 generation backK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- This deviceK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015 · cites it directly43descendants
- K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016 · 2 generations on40descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · cites it directly39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 2 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −9 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −8 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −6 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −5 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −4 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −3 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −2 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| −1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| 0 (this device) | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +1 | K151019 | SternaLock® 360 Sternal Closure System | Biomet Microfixation | 2015 | — |
| +2 | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Biomet Microfixation | 2016 | — |
| +1 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +2 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 15 | 0 |
| 2025 | 14 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011076 | Lorenz Sternal Closure System with Modular Screw | 2001 |
| * | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure SystemSummary page 2…valence: Biomet Microfixation considers the Biomet Microfixation Sternal Closure System to be equivalent to the Biomet Microfixation Sternal Closure System (KOl 1076, KI 110574 and KI 111908). There are no changes to the screws. The SternaLock (sometimes abbreviated SL) system of plates, including the Ste… | 2011 |
| * | K111908 | Biomet Microfixation Sternal Closure SystemSummary page 2…t Microfixation considers the Biomet Microfixation Sternal Closure System to be equivalent to the Biomet Microfixation Sternal Closure System (KOl 1076, KI 110574 and KI 111908). There are no changes to the screws. The SternaLock (sometimes abbreviated SL) system of plates, including the SternaL-ock Blu s… | 2011 |
What descends from it? (75)
See all 758 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151019 | SternaLock® 360 Sternal Closure System | 2015 | 43 |
| K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | 2021 | 39 |
| K142823 | Biomet Microfixation Thoracic Fixation System | 2015 | 23 |
| K161896 | Biomet Microfixation Sternal Closure System | 2016 | 4 |
| K183172 | Stryker SternalPlate System | 2019 | 1 |
| K142484 | Sternal Closure System | 2014 | 1 |
| K210290 | JACE Medical Thoracic Plating System | 2021 | 0 |
| K181806 | ARIX Sternal System | 2018 | 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?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K151019 (Biomet Microfixation, 2015) has gone furthest, with 43 descendants of its own.
- 8 other devices also cite its predicate K011076.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121302 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121302: Biomet Microfixation Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121302
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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