510(k) · Cleared
ClearedLactosorb Panels
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 Jan 30, 1998 after a 74-day review. The FDA summary names its predicate without a number. 167 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
167 later devices descend from it, 7 citing it directly.
- This deviceK974309 Lactosorb PanelsBiomet, Inc. · 1998
- Descendant · cites it directly · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · cites it directly · 74 of its ownK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · 2 generations on · 72 of its ownK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · cites it directly86descendants
- K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
- K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003 · cites it directly74descendants
- K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
- K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004 · 2 generations on72descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974309 | Lactosorb Panels | Biomet, Inc. | 1998 | — |
| +1 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| +2 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +1 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| +1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +2 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 17 | 0 |
| 2025 | 18 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | — | LactoSorb mesh in the LactoSorb Trauma Plating System Named without a submission number | |
| * | — | thin metal meshes Named without a submission number |
What descends from it? (167)
See all 1677 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | 1998 | 86 |
| K032698 | Coapt Endotine Midface-ST 4.5 Device | 2003 | 74 |
| K011590 | Resorb-X Resorbable Plating System | 2002 | 73 |
| K033524 | Coapt Endotine Chin 3.5 Device | 2003 | 3 |
| K040740 | Endotine Transbleph Device | 2004 | 2 |
| K030425 | Lorenz Resorbable Distraction System or Expander | 2004 | 1 |
| K041835 | Endotine Midface B 4.5 Device | 2004 | 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, K982139 (Bionx Implants, Inc., 1998) has gone furthest, with 86 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: 1. comminuted fractures of the naso-ethmoidal infraobital areas 2. comminuted fractures of the frontal sinus wall 3. pediatric midface or craniofacial trauma 4. orbital floor fractures 5. trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones B. General Indication: reconstructive procedures of the…
Read the full statement (117 words)
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
1. comminuted fractures of the naso-ethmoidal infraobital areas
2. comminuted fractures of the frontal sinus wall
3. pediatric midface or craniofacial trauma
4. orbital floor fractures
5. 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:
1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
2. tumor reconstruction in midface or craniofacial procedures
3. bone graft procedures in the midface or craniofacial skeleton
4. pediatric reconstructive procedures
5. reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
6. 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/K974309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974309: Lactosorb Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974309
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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