510(k) · Cleared
ClearedLactosorb Trauma Plating 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 Dec 20, 1999 after a 159-day review. The FDA summary names no predicate by number. 14 later devices descend from it.
- Decided
- Dec 20, 1999
- Review
- 159 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK992355 Lactosorb Trauma Plating SystemBiomet, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK051341 Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole…Inion, Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK033918 Ebi Lactosorb Graft Containment SystemEbi, L.P. · 2004
- Descendant · cites it directly · 2 of its ownK112064 Resorb X-GKLS-Martin L.P. · 2012
- Descendant · cites it directly · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK073115 OrthomeshSynthes (Usa) · 2008
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K051341Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058…Inion, Ltd. · 2005 · cites it directly3descendants
- K033918Ebi Lactosorb Graft Containment SystemEbi, L.P. · 2004 · cites it directly3descendants
- K112064Resorb X-GKLS-Martin L.P. · 2012 · cites it directly2descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · cites it directly2descendants
- K073115OrthomeshSynthes (Usa) · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992355 | Lactosorb Trauma Plating System | Biomet, Inc. | 1999 | — |
| +1 | K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates… | Inion, Ltd. | 2005 | — |
| +1 | K033918 | Ebi Lactosorb Graft Containment System | Ebi, L.P. | 2004 | — |
| +1 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| +1 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +2 | K073115 | Orthomesh | Synthes (Usa) | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051341 | Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058… | 2005 | 3 |
| K033918 | Ebi Lactosorb Graft Containment System | 2004 | 3 |
| K112064 | Resorb X-G | 2012 | 2 |
| K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | 2008 | 2 |
| K141385 | Depuy Synthes Injectable Polymer System (Ips) | 2015 | 0 |
| K121606 | Resorb-X G | 2013 | 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?
- Of its descendants, K051341 (Inion, Ltd., 2005) has gone furthest, with 3 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?
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: Comminuted fractures of the naso-ethmoidal infraorbital areas Comminuted fractures of the frontal sinus wall Pediatric midface or craniofacial trauma LeFort (LILIII) fractures Orbital floor fractures Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones Trauma of the craniofacial skeleton including: frontal…
Read the full statement (126 words)
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
Comminuted fractures of the naso-ethmoidal infraorbital areas
Comminuted fractures of the frontal sinus wall
Pediatric midface or craniofacial trauma
LeFort (LILIII) fractures
Orbital floor fractures
Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
Specific Indications:
Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
LeFort (LILIII) osteotomies
Tumor reconstruction in midface or craniofacial procedures
Bone graft procedures in the midface or craniofacial skeleton
Pediatric reconstructive procedures
Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
Craniotomy flap fixation
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/K992355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992355: Lactosorb Trauma Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992355
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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