510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Zindrick IM Rod

K871539510(k) TraditionalCleared Aug 17, 1987119-day reviewClass II21 CFR 888.3020Recalls 1

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

Buckman Co., Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Aug 17, 1987 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it. It has been recalled once.

Decided
Aug 17, 1987
Review
119 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2006: 1 descendant cleared2003: 1 descendant cleared2004: 2 descendants cleared2002: 1 descendant cleared2010: 3 descendants cleared2012: 3 descendants cleared2011: 2 descendants cleared2009: 3 descendants cleared2014: 3 descendants cleared2015: 2 descendants cleared2023: 5 descendants cleared2013: 2 descendants cleared2020: 5 descendants cleared2017: 2 descendants cleared2018: 8 descendants cleared2024: 5 descendants cleared2021: 3 descendants cleared2026: 5 descendants cleared2019: 4 descendants cleared2025: 8 descendants cleared2022: 6 descendants cleared1990200020102020
  1. This deviceK871539 Zindrick IM RodBuckman Co., Inc. · 1987
  2. Descendant · cites it directly · 70 of its ownK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
  3. Descendant · cites it directly · 53 of its ownK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
  4. Descendant · 2 generations on · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
  5. Descendant · 2 generations on · 29 of its ownK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
  6. Descendant · 3 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 22006: 12009: 32010: 32011: 22012: 32013: 22014: 32015: 22017: 22018: 82019: 42020: 52021: 32022: 62023: 52024: 52025: 82026: 5
2001high 8 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 75 · See all
  • K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly70descendants
  • K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003 · cites it directly53descendants
  • K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · 2 generations on39descendants
  • K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · 2 generations on29descendants
  • K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 3 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871539Zindrick IM RodBuckman Co., Inc.1987—
+1K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.200154
+1K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.2003—
+2K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…Zimmer, Inc.200916
+2K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.20103
+3K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…Stryker Trauma GmbH2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200420
200610
200930
201030
201120
201230
201320
201430
201520
201720
201880
201940
202050
202130
202260
202350
202450
202580
202650
FIG. 1 — Lineage of K871539, 1987–2026Source: 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 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
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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? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.200170
K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.200353
K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH20063

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 1, 2016Class IIZ-1819-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K013563 (DePuy Orthopaedics, Inc., 2001) has gone furthest, with 70 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 Buckman Co., Inc.

111 FDA decisions under this applicant name. See the company

  • K961320Cross Medical Bone Plate System/ CM Bone Plate System/Cross TI Bone Plate SystemBuckman Co., Inc. · 1998
  • K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
  • K964252OrthochuckBuckman Co., Inc. · 1997
  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  • K960451Webb-Morley Spine SystemBuckman Co., Inc. · 1996

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K871539 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871539: Zindrick IM Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871539

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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