510(k) · Cleared
ClearedAcute Innovations Biobridge Resorbable Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acute Innovations, LLC · HRS Plate, Fixation, Bone
Cleared on Feb 17, 2012 as substantially equivalent to K081588 (Acute Innovations, LLC, 2008) after a 29-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Feb 17, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974017 (1998). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 4 generations backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- 3 generations backK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
- 2 generations backK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
- 1 generation backK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008
- This deviceK120163 Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −4 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| −3 | K031961 | Inion Otps Biodegradable Mesh Plating System | Inion, Ltd. | 2004 | — |
| −2 | K063410 | Inion CPS/Otps Freedomplate | Inion, Ltd. | 2007 | — |
| −1 | K081588 | RE-Zorb Plating System | Acute Innovations, LLC | 2008 | — |
| 0 (this device) | K120163 | Acute Innovations Biobridge Resorbable Plating System | Acute Innovations, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K081588 | RE-Zorb Plating SystemSummary page 1…bone fixation appliances and accessories Class: 11 Product Code: H-RS Predicate: K08 1588 Re-Zorb Plating System (Acute Innovations) (now called RioBridge® Plating System) Indications… | 2008 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 11 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. 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?
General Indications:
In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.
Specific indications:
1. Metacarpus, proximal and middle phalangeal bones
2. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120163: Acute Innovations Biobridge Resorbable Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120163
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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