510(k) · Cleared
ClearedLactosorb Hand System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 30, 1999 after a 67-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Jul 30, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK991763 Lactosorb Hand SystemBiomet, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK023887 Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2003
- Descendant · 2 generations on · 2 of its ownK063410 Inion CPS/Otps FreedomplateInion, Ltd. · 2007
- Descendant · 3 generations on · 1 of its ownK081588 RE-Zorb Plating SystemAcute Innovations, LLC · 2008
- Descendant · 4 generations on · 0 of its ownK120163 Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK050388 Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
Most influential descendants
Showing 5 of 5 · See all- K023887Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2003 · cites it directly4descendants
- K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007 · 2 generations on2descendants
- K081588RE-Zorb Plating SystemAcute Innovations, LLC · 2008 · 3 generations on1descendant
- K120163Acute Innovations Biobridge Resorbable Plating SystemAcute Innovations, LLC · 2012 · 4 generations on0descendants
- K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991763 | Lactosorb Hand System | Biomet, Inc. | 1999 | — |
| +1 | K023887 | Inion Otps Biodegradable Mini Plating System | Inion, Ltd. | 2003 | — |
| +2 | K063410 | Inion CPS/Otps Freedomplate | Inion, Ltd. | 2007 | — |
| +3 | K081588 | RE-Zorb Plating System | Acute Innovations, LLC | 2008 | — |
| +4 | K120163 | Acute Innovations Biobridge Resorbable Plating System | Acute Innovations, LLC | 2012 | — |
| +2 | K050388 | Refix Internal Fracture Fixation Screws | Xtremi-T, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023887 | Inion Otps Biodegradable Mini Plating System | 2003 | 4 |
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?
- Of its descendants, K023887 (Inion, Ltd., 2003) has gone furthest, with 4 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.
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 LactoSorb® Hand System is indicated for surgical fixation of closed non-comminuted diaphyseal metacarpal fractures in the presence of appropriate immobilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991763: Lactosorb Hand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991763
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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