510(k) Report

510(k) · Cleared

Cleared

Aginsky Nail

K803106510(k) TraditionalCleared Feb 12, 198165-day reviewClass II21 CFR 888.3020

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

Cintor Orthopaedic Div. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 12, 1981 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Feb 12, 1981
Review
65 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2001: 1 descendant cleared2003: 3 descendants cleared2007: 2 descendants cleared2002: 2 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2004: 4 descendants cleared2015: 2 descendants cleared2013: 4 descendants cleared2016: 3 descendants cleared2006: 1 descendant cleared2012: 1 descendant cleared2017: 3 descendants cleared2020: 5 descendants cleared2018: 2 descendants cleared2019: 3 descendants cleared2009: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2014: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared19801990200020102020
  1. This deviceK803106 Aginsky NailCintor Orthopaedic Div. · 1981
  2. Descendant · cites it directly · 56 of its ownK990717 Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999
  3. Descendant · 2 generations on · 54 of its ownK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
  4. Descendant · 2 generations on · 54 of its ownK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
  5. Descendant · 2 generations on · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  6. Descendant · 2 generations on · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12002: 22003: 32004: 42006: 12007: 22009: 12010: 22011: 32012: 12013: 42014: 22015: 22016: 32017: 32018: 22019: 32020: 52021: 22022: 22023: 22024: 22025: 22026: 2
1999high 5 (2020) · low 0 (2000)2026

Most influential descendants

Showing 5 of 57 · See all
  • K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999 · cites it directly56descendants
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on54descendants
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · 2 generations on54descendants
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on53descendants
  • K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K803106Aginsky NailCintor Orthopaedic Div.1981—
+1K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.1999—
+2K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.20021
+2K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.2001—
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—
+2K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200220
200330
200440
200610
200720
200910
201020
201130
201210
201340
201420
201520
201630
201730
201820
201930
202050
202120
202220
202320
202420
202520
202620
FIG. 1 — Lineage of K803106, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.199956

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, K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) has gone furthest, with 56 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

More from Cintor Orthopaedic Div.

7 FDA decisions under this applicant name. See the company

  • K811451Radial Head ProsthesisCintor Orthopaedic Div. · 1981
  • K810540Knee ProsthesisCintor Orthopaedic Div. · 1981
  • K810353Harris Cement RestrictorCintor Orthopaedic Div. · 1981
  • K803074Fernoral Hip ProsthesisCintor Orthopaedic Div. · 1981
  • K802627Ortron 90* Hip ProsthesisCintor Orthopaedic Div. · 1980

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The HSB category page

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https://510kreport.com/device/K803106 · printed Nov 4, 2026

Cite this page

510(k) Report. “K803106: Aginsky Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K803106

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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