510(k) Report

510(k) · Cleared

Cleared

Affixus® Natural Nail® Proximal Humeral System

K253749510(k) SpecialCleared Dec 12, 202517-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

Zimmer Switzerland Manufacturing GmbH · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 12, 2025 as substantially equivalent to K231114 (Zimmer Switzerland Manufacturing GmbH, 2023) and 4 other predicates after a 17-day review. Its family tree reaches back 8 generations to 1997.

Decided
Dec 12, 2025
Review
17 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
5

Its longest line of descent runs back 8 generations to K970097 (1997). 31 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2023: 1 other ancestor2004: 3 other ancestors2009: 2 other ancestors2002: 3 other ancestors2001: 4 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2003: 1 other ancestor1996: 2 other ancestors2005: 1 other ancestor1998: 2 other ancestors1987: 1 other ancestorK970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 1997K973240 · Synthes Proximal Femoral Nail (PFN) System Modification · Synthes (Usa) · 1997K013563 · Long Trochanteric Nail System · DePuy Orthopaedics, Inc. · 2001 · recalledK033329 · Depuy Ace Universal and Troch Entry Femoral Nail Systems · Depuy, Inc. · 2003K101622 · Zimmer Natural Nail System Retrograde Femoral Nails · Zimmer, Inc. · 2010 · recalledK142281 · Zimmer M/DN Intramedullary Fixation System · Zimmer, Inc. · 2014 · recalledK181827 · Affixus Natural Nail System Humeral Nail · Zimmer GmbH · 2018K200814 · Affixus (R) Natural Nail (R) System Humeral Nail · Zimmer GmbH · 20201990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor5 generations back: 8 other ancestors6 generations back: 1 other ancestor K200814 · Affixus (R) Natural Nail (R) System Humeral Nail · Zimmer GmbH · 2020K181827 · Affixus Natural Nail System Humeral Nail · Zimmer GmbH · 2018K142281 · Zimmer M/DN Intramedullary Fixation System · Zimmer, Inc. · 2014 · recalledK101622 · Zimmer Natural Nail System Retrograde Femoral Nails · Zimmer, Inc. · 2010 · recalledK033329 · Depuy Ace Universal and Troch Entry Femoral Nail Systems · Depuy, Inc. · 2003K013563 · Long Trochanteric Nail System · DePuy Orthopaedics, Inc. · 2001 · recalledK973240 · Synthes Proximal Femoral Nail (PFN) System Modification · Synthes (Usa) · 1997K970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 1997−50
  1. Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 7 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
  3. 6 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
  4. 5 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
  5. 4 generations backK101622 Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc. · 2010 · Recalled
  6. 3 generations backK142281 Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc. · 2014 · Recalled
  7. 2 generations backK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
  8. 1 generation backK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
  9. This deviceK253749 Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−7K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa)1997—
−6K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.200154
−5K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.2003—
−4K101622Zimmer Natural Nail System Retrograde Femoral NailsZimmer, Inc.20103
−3K142281Zimmer M/DN Intramedullary Fixation SystemZimmer, Inc.20147
−2K181827Affixus Natural Nail System Humeral NailZimmer GmbH2018—
−1K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH2020—
0 (this device)K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
199510
199620
199710
199820
200140
200230
200310
200430
200510
200920
202310
FIG. 1 — Lineage of K253749, 1997–2025Source: 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
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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
*K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…
Summary page 5
…888.3020 Product Code(s) HSB I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231114 Affixus® Natural Nail® Humeral Nail System HSB K200814 Affixus® Natural Nail® System Humeral Nail HSB K181827 Affixus® Natural Na…
Zimmer Switzerland Manufacturing GmbH2023—
*K200814Affixus (R) Natural Nail (R) System Humeral Nail
Summary page 5
…cate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231114 Affixus® Natural Nail® Humeral Nail System HSB K200814 Affixus® Natural Nail® System Humeral Nail HSB K181827 Affixus® Natural Nail® System Humeral Nail HSB K033806 ACE PROXIMAL HUMERA…
Zimmer GmbH2020—
*K181827Affixus Natural Nail System Humeral Nail
Summary page 5
…Trade Name (Primary Predicate is listed first) Product Code K231114 Affixus® Natural Nail® Humeral Nail System HSB K200814 Affixus® Natural Nail® System Humeral Nail HSB K181827 Affixus® Natural Nail® System Humeral Nail HSB K033806 ACE PROXIMAL HUMERAL NAIL SYSTEM HSB K033878 ACE ANTEGRADE RETROGRADE HUME…
Zimmer GmbH2018—
*K033806Ace Proximal Humeral Nail System
Summary page 5
…Code K231114 Affixus® Natural Nail® Humeral Nail System HSB K200814 Affixus® Natural Nail® System Humeral Nail HSB K181827 Affixus® Natural Nail® System Humeral Nail HSB K033806 ACE PROXIMAL HUMERAL NAIL SYSTEM HSB K033878 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM HSB | Device Description Summary 21 CFR…
Depuy Ace2004—
*K033878Ace Antegrade Retrograde Humeral Nail System
Summary page 5
…ail System HSB K200814 Affixus® Natural Nail® System Humeral Nail HSB K181827 Affixus® Natural Nail® System Humeral Nail HSB K033806 ACE PROXIMAL HUMERAL NAIL SYSTEM HSB K033878 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM HSB | Device Description Summary 21 CFR 807.92(a)(4) The Affixus® Natural Nail® Hum…
Depuy Ace2004—

Also cleared against K231114: 1 other device →

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 28 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
  • 16 of the 31 ancestors have a recall of any class.
  • 1 other device also cites its predicate K231114.

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. 2025, 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?

The Affixus Natural Nail Humeral Nail System nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.

The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:

* Proximal fractures (proximal short and long nails only)

* Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only)

* Open and closed fractures

* Comminuted fractures

* Nonunions and malunions

* Pathologic fractures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K231114

1 other device cites the same predicate.

  • K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 202417 recalls

More from Zimmer Switzerland Manufacturing GmbH

4 FDA decisions under this applicant name. See the company

  • K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB®…Zimmer Switzerland Manufacturing GmbH · 2024
  • K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail SystemZimmer Switzerland Manufacturing GmbH · 2023
  • K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH · 2021

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/K253749 · printed Nov 5, 2026

Cite this page

510(k) Report. “K253749: Affixus® Natural Nail® Proximal Humeral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253749

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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