510(k) · Cleared
ClearedSternaFuse Ti Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Innovations, LLC · HRS Plate, Fixation, Bone
Cleared on Nov 19, 2025 as substantially equivalent to K202914 (Fusion Innovations, LLC, 2022) and 1 other predicate after an 89-day review. Its family tree reaches back 11 generations to 1976.
- Decided
- Nov 19, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K761228 (1976). 28 ancestors in all. No later device cites it as a predicate yet.
- 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 backK202914 SternaFuse Fixation SystemFusion Innovations, LLC · 2022
- This deviceK252661 SternaFuse Ti Fixation SystemFusion Innovations, LLC · 2025
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 backK202914 SternaFuse Fixation SystemFusion Innovations, LLC · 2022
- This deviceK252661 SternaFuse Ti Fixation SystemFusion Innovations, LLC · 2025
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 | K202914 | SternaFuse Fixation System | Fusion Innovations, LLC | 2022 | — |
| 0 (this device) | K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K202914 | SternaFuse Fixation System Our reading of the summary gave K202904, FDA’s number for Surgical Face Mask (Jiangxi Feilikang Medical Technology Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SternaFuse Fixation System”. | 2022 |
| * | K111908 | Biomet Microfixation Sternal Closure System | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 49 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 28 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion . The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252661: SternaFuse Ti 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/K252661
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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