510(k) · Cleared
Recalled · 2004Lactosorb Bone Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HTY Pin, Fixation, Smooth
Cleared on Mar 23, 1999 after a 53-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 23, 1999
- Review
- 53 days
- Class
- Class II
- Product code
- HTY
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK990291 Lactosorb Bone PinBiomet, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK043339 Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models…Xtremi-T, LLC · 2005
- Descendant · 2 generations on · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK140625 Orthosorb LSBiomet, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK011451 Reunite Fusion ScrewBiomet, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC · 2005 · cites it directly1descendant
- K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015 · 2 generations on0descendants
- K140625Orthosorb LSBiomet, Inc. · 2014 · cites it directly0descendants
- K011451Reunite Fusion ScrewBiomet, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990291 | Lactosorb Bone Pin | Biomet, Inc. | 1999 | — |
| +1 | K043339 | Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG… | Xtremi-T, LLC | 2005 | — |
| +2 | K151876 | Bio2 Fusion Implant System | Bio2 Technologies, Inc. | 2015 | — |
| +1 | K140625 | Orthosorb LS | Biomet, Inc. | 2014 | — |
| +1 | K011451 | Reunite Fusion Screw | Biomet, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 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? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2004 | Not classified | Z-0013-05 | Other | Mislabeled as to size; 1.55 mm pins are labeled as 2mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043339 (Xtremi-T, LLC, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The LactoSorb® Bone Pin is indicated for use in the presence of appropriate
immobilization in the following procedures:
1. correction of hallux valgus (bunion)
2. repair of metacarpal and phalangeal fusion and fractures
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/K990291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990291: Lactosorb Bone Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990291
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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