510(k) · Cleared
ClearedRE-Zorb 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 Sep 3, 2008 as substantially equivalent to K063410 (Inion, Ltd., 2007) after a 90-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Sep 3, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974017 (1998). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 3 generations backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- 2 generations backK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
- 1 generation backK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
- This deviceK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008
- Descendant · cites it directly · 0 of its ownK120163 Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −3 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| −2 | K031961 | Inion Otps Biodegradable Mesh Plating System | Inion, Ltd. | 2004 | — |
| −1 | K063410 | Inion CPS/Otps Freedomplate | Inion, Ltd. | 2007 | — |
| 0 (this device) | K081588 | RE-Zorb Plating System | Acute Innovations, LLC | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K063410 | Inion CPS/Otps FreedomplateSummary page 1…e: Re-ZorbTM Plating System Proposed Regulatory Class: Class 11, 21 CFR 888.3030 Device Product Code: HRS Legally Marketed Equivalent Device(s): Inion FreedomPlateTM (K 063410) Intended Use: In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120163 | Acute Innovations Biobridge Resorbable Plating System | 2012 | 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 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K120163 (Acute Innovations, LLC, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
2. Metacarpus, proximal and middle phalangeal bones
3. 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/K081588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081588: RE-Zorb Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081588
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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