510(k) Report

510(k) · Cleared

Cleared

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt

K172189510(k) TraditionalCleared Jan 16, 2018180-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

Truemed Group, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jan 16, 2018 as substantially equivalent to K133166 (Truemed Group, LLC, 2014) and 4 other predicates after a 180-day review. Its family tree reaches back 5 generations to 1998.

Decided
Jan 16, 2018
Review
180 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K981372 (1998). 24 ancestors in all, the oldest K914453 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor2004: 2 other ancestors2003: 1 other ancestor2001: 5 other ancestors1996: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor2000: 4 other ancestors1999: 1 other ancestor1997: 1 other ancestor1998: 1 other ancestorK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K162507 · Arzzt 3.5 / 4.5 Small & Large Fragments System · Truemed Group, LLC · 20171990199520002005201020152020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 6 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors K162507 · Arzzt 3.5 / 4.5 Small & Large Fragments System · Truemed Group, LLC · 2017K082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998−50
  1. Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. 1 generation backK162507 Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC · 2017
  6. This deviceK172189 Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins…Truemed Group, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−4K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−3K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−2K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
−1K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC2017—
0 (this device)K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden…Truemed Group, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199610
199710
199810
199910
200040
200150
200310
200420
201410
FIG. 1 — Lineage of K172189, 1998–2018Source: 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 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? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K133166Ins Hilden Tibial Arzzt
Summary page 4
…odes: HSB 8. Devices Classification: Class II 9. Regulation Numbers: 21 CFR 888.3020. 10. Predicate Devices: Ins Hilden Tibial Arzzt K133166 DEPUY ACE Antegrade Retrograde Humeral Nail System K033878 DEPUY…
Truemed Group, LLC2014—
*K033878Ace Antegrade Retrograde Humeral Nail System
Summary page 4
…21 CFR 888.3020. 10. Predicate Devices: Ins Hilden Tibial Arzzt K133166 DEPUY ACE Antegrade Retrograde Humeral Nail System K033878 DEPUY ACE VERSANAIL TIBIAL NAIL K032097 T2 Femoral Nail (K010801)…
Depuy Ace2004—
*K032097Depuy Ace Versanail Tibial Nail
Summary page 4
…Arzzt K133166 DEPUY ACE Antegrade Retrograde Humeral Nail System K033878 DEPUY ACE VERSANAIL TIBIAL NAIL K032097 T2 Femoral Nail (K010801) ARZZT 3.5/4.5 Small and Large Fragment…
DePuy Orthopaedics, Inc.2003—
*K010801T2 Femoral Nail
Summary page 4
…Antegrade Retrograde Humeral Nail System K033878 DEPUY ACE VERSANAIL TIBIAL NAIL K032097 T2 Femoral Nail (K010801) ARZZT 3.5/4.5 Small and Large Fragment System (K162507) Devices…
Howmedica Osteonics Corp.20012
*K162507Arzzt 3.5 / 4.5 Small & Large Fragments System
Cleared while this submission was under review
Summary page 4
…E VERSANAIL TIBIAL NAIL K032097 T2 Femoral Nail (K010801) ARZZT 3.5/4.5 Small and Large Fragment System (K162507) Devices Description: I. The Ins Hilden Humeral Arzzt is a single…
Truemed Group, LLC2017—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
  • 6 of the 24 ancestors have a recall of any class.

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. 2018, this device’s year, is highlighted.

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—

What is it indicated for?

Ins Hilden Arzzt Nail Systems, consisting of intramedullary solid and cannulated nails, end cap and locking screws, are intended for fixation of fractures of different types: of the shaft, open and closed shaft fractures; and malunion and non-unions of the Femur, Tibia, and Humerus.

Indications for use as stated in the FDA summary.

More from Truemed Group, LLC

5 FDA decisions under this applicant name. See the company

  • K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC · 2021
  • K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC · 2019
  • K162507Arzzt 3.5 / 4.5 Small & Large Fragments SystemTruemed Group, LLC · 2017
  • K133166Ins Hilden Tibial ArzztTruemed Group, LLC · 2014

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/K172189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172189: Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172189

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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