510(k) Report

510(k) · Cleared

Cleared

Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260

K003659510(k) TraditionalCleared Feb 20, 200184-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

Bionx Implants, Inc. · HTY Pin, Fixation, Smooth

Cleared on Feb 20, 2001 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided
Feb 20, 2001
Review
84 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2004: 1 descendant cleared2005: 1 descendant cleared2008: 2 descendants cleared2007: 2 descendants cleared2015: 5 descendants cleared2014: 3 descendants cleared2013: 1 descendant cleared2020: 2 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2021: 3 descendants cleared2024: 4 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 4 descendants cleared200020052010201520202025
  1. This deviceK003659 Plga Pin, Model…Bionx Implants, Inc. · 2001
  2. Descendant · cites it directly · 37 of its ownK061164 ActivapinBioretec, Ltd. · 2006
  3. Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  4. Descendant · 3 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  5. Descendant · 4 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
  6. Descendant · 5 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22007: 22008: 22013: 12014: 32015: 52016: 22017: 12018: 12019: 42020: 22021: 32023: 22024: 42025: 32026: 4
2004high 5 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 43 · See all
  • K061164ActivapinBioretec, Ltd. · 2006 · cites it directly37descendants
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 3 generations on16descendants
  • K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 4 generations on15descendants
  • K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003659Plga Pin, Model…Bionx Implants, Inc.2001—
+1K061164ActivapinBioretec, Ltd.2006—
+2K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+3K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC2015—
+5K181872MIS Bunion SystemCrossroads Extremity Systems, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200720
200820
201310
201430
201550
201620
201710
201810
201940
202020
202130
202320
202440
202530
202640
FIG. 1 — Lineage of K003659, 2001–2026Source: 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
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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? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K061164ActivapinBioretec, Ltd.200637
K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042
K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051

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, K061164 (Bioretec, Ltd., 2006) has gone furthest, with 37 descendants 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—

More from Bionx Implants, Inc.

18 FDA decisions under this applicant name. See the company

  • K023022Nugen FX ScrewBionx Implants, Inc. · 2002
  • K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
  • K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
  • K013057Biocuff,C, Models 236018, 236028, 236036Bionx Implants, Inc. · 2001
  • K012334Contour Meniscus Arrow, Models 541110, 541113, and 541116Bionx Implants, Inc. · 2001

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The HTY category page

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https://510kreport.com/device/K003659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003659: Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003659

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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