510(k) Report

510(k) · Cleared

Cleared

Lactosorb Bone Pin

K953194510(k) TraditionalCleared Oct 31, 1995113-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet, Inc. · HTY Pin, Fixation, Smooth

Cleared on Oct 31, 1995 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 31, 1995
Review
113 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2001: 1 descendant cleared2005: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953194 Lactosorb Bone PinBiomet, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK043339 Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models…Xtremi-T, LLC · 2005
  3. Descendant · 2 generations on · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015
  4. Descendant · cites it directly · 0 of its ownK011451 Reunite Fusion ScrewBiomet, Inc. · 2001
  5. Descendant · cites it directly · 0 of its ownK970036 Fixation Pin or RodUnited States Surgical, A Division of Tyco Healthc · 1997

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
  • K011451Reunite Fusion ScrewBiomet, Inc. · 2001 · cites it directly0descendants
  • K970036Fixation Pin or RodUnited States Surgical, A Division of Tyco Healthc · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953194Lactosorb Bone PinBiomet, Inc.1995—
+1K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG…Xtremi-T, LLC2005—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.2015—
+1K011451Reunite Fusion ScrewBiomet, Inc.2001—
+1K970036Fixation Pin or RodUnited States Surgical, A Division of Tyco Healthc1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200510
201510
FIG. 1 — Lineage of K953194, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051
K011451Reunite Fusion ScrewBiomet, Inc.20010
K970036Fixation Pin or RodUnited States Surgical, A Division of Tyco Healthc19970

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, K043339 (Xtremi-T, LLC, 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

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https://510kreport.com/device/K953194 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953194: 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/K953194

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026