510(k) Report

510(k) · Cleared

Cleared

Nancy Nail

K960642510(k) TraditionalCleared May 17, 199693-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

Landos, Inc. · HTY Pin, Fixation, Smooth

Cleared on May 17, 1996 after a 93-day review. The FDA summary names no predicate by number. 50 later devices descend from it.

Decided
May 17, 1996
Review
93 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
0

50 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2017: 5 descendants cleared2024: 5 descendants cleared2015: 2 descendants cleared2003: 2 descendants cleared2008: 4 descendants cleared2004: 2 descendants cleared2022: 3 descendants cleared2018: 1 descendant cleared2025: 6 descendants cleared2016: 2 descendants cleared2021: 5 descendants cleared2012: 1 descendant cleared2020: 5 descendants cleared2026: 5 descendants cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960642 Nancy NailLandos, Inc. · 1996
  2. Descendant · cites it directly · 49 of its ownK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
  3. Descendant · 2 generations on · 29 of its ownK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
  4. Descendant · 2 generations on · 17 of its ownK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
  5. Descendant · 2 generations on · 15 of its ownK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
  6. Descendant · 3 generations on · 14 of its ownK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1997: 12003: 22004: 22008: 42012: 12015: 22016: 22017: 52018: 12020: 52021: 52022: 32023: 12024: 52025: 62026: 5
1997high 6 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 50 · See all
  • K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997 · cites it directly49descendants
  • K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008 · 2 generations on29descendants
  • K032687Ace Nancy NailDePuy Orthopaedics, Inc. · 2003 · 2 generations on17descendants
  • K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · 2 generations on15descendants
  • K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa) · 2008 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960642Nancy NailLandos, Inc.1996—
+1K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)1997—
+2K081452Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa)2008—
+2K032687Ace Nancy NailDePuy Orthopaedics, Inc.2003—
+2K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc.20034
+3K082148Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSynthes (Usa)2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200320
200420
200840
201210
201520
201620
201750
201810
202050
202150
202230
202310
202450
202560
202650
FIG. 1 — Lineage of K960642, 1996–2026Source: 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), 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. #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?

The FDA summary names no predicate by number.

What descends from it? (50)

See all 50

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971783Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa)199749

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, K971783 (Synthes (Usa), 1997) has gone furthest, with 49 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 Landos, Inc.

15 FDA decisions under this applicant name. See the company

  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  • K97106834MM Scarf Thread-Head (TM) ScrewLandos, Inc. · 1997
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 1997
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
  • K961732KARLandos, Inc. · 1997

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https://510kreport.com/device/K960642 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960642: Nancy Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960642

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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