510(k) Report

510(k) · Cleared

Cleared

Ace Antegrade Retrograde Humeral Nail System

K033878510(k) TraditionalCleared Feb 20, 200467-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

Depuy Ace · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 20, 2004 as substantially equivalent to K934643 (Ace Orthopedic Manufacturing Co., 1994) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided
Feb 20, 2004
Review
67 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K934643 (1994). 2 ancestors in all. 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2018: 2 descendants cleared2012: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK934643 · Ace Humeral Nail · Ace Orthopedic Manufacturing Co. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K934643 · Ace Humeral Nail · Ace Orthopedic Manufacturing Co. · 19940
  1. Root · 1 generation backK934643 Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
  2. This deviceK033878 Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004
  3. Descendant · cites it directly · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
  4. Descendant · 2 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
  5. Descendant · 3 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
  7. Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012: 12018: 22020: 12023: 12024: 12025: 32026: 1
2012high 3 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all
  • K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · cites it directly6descendants
  • K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 2 generations on4descendants
  • K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 3 generations on2descendants
  • K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · 2 generations on1descendant
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934643Ace Humeral NailAce Orthopedic Manufacturing Co.1994—
0 (this device)K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace2004—
+1K181827Affixus Natural Nail System Humeral NailZimmer GmbH2018—
+2K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®…Zimmer Switzerland Manufacturing GmbH2023—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.202417
+2K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH2020—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.201217

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201820
202010
202310
202410
202530
202610
FIG. 1 — Lineage of K033878, 1994–2026Source: 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 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? (2)

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
*K934643Ace Humeral Nail
Summary page 1
…Intramedullary Fixation Rod DEVICE PRODUCT CODE: 87 HSB SUBSTANTIALLY EQUIVALENT DePuy ACE®'AIM Humeral Nail, K934643 DEVICES: Howmiedica Osteonics Corp T2 Humieral Nail…
Ace Orthopedic Manufacturing Co.1994—
*K011529T2 Humeral Nail System
Summary page 1
…dica Osteonics Corp T2 Humieral Nail T System, K01 1529 DEVICE DESCRIPTION: The ACE® Antegrade Retrograde (A/R) Humieral Nail System includes an intramedullary nai, cancellous and c…
Howmedica Osteonics Corp.20013

Also cleared against K934643: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K181827Affixus Natural Nail System Humeral NailZimmer GmbH20186
K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.20121
K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250
K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K181827 (Zimmer GmbH, 2018) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K934643.

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—

What is it indicated for?

The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Indications for use as stated in the FDA summary.

Also cleared against K934643

1 other device cites the same predicate.

  • K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2006

More from Depuy Ace

2 FDA decisions under this applicant name. See the company

  • K033806Ace Proximal Humeral Nail SystemDepuy Ace · 2004

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/K033878 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033878: Ace Antegrade Retrograde Humeral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033878

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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