510(k) Report

510(k) · Cleared

Cleared

Zimmer Natural Nail System

K172114510(k) SpecialCleared Aug 10, 201728-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, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Aug 10, 2017 as substantially equivalent to K083497 (Zimmer, Inc., 2009) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1997. 11 later devices descend from it.

Decided
Aug 10, 2017
Review
28 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K970097 (1997). 18 ancestors in all, the oldest K871539 (1987). 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2005: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors2004: 1 other ancestor2002: 2 other ancestors2001: 2 other ancestors1998: 2 other ancestors1987: 1 other ancestor2018: 1 descendant cleared2020: 1 descendant cleared2022: 3 descendants cleared2025: 3 descendants cleared2024: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK970097 · 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. · 2003K083497 · Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails · Zimmer, Inc. · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 8 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants K083497 · Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails · Zimmer, Inc. · 2009 · 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 · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
  3. 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
  4. 2 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
  5. 1 generation backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
  6. This deviceK172114 Zimmer Natural Nail SystemZimmer, Inc. · 2017
  7. Descendant · cites it directly · 9 of its ownK200869 Gamma3 SystemStryker Trauma GmbH · 2020
  8. Descendant · 2 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK242247 ARIX Femur Nail SystemJeil Medical Corporation · 2025
  10. Descendant · 2 generations on · 0 of its ownK261043 AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026
  11. Descendant · 2 generations on · 0 of its ownK252826 ARIX Femur Nail SystemJeil Medical Corporation · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2018: 12020: 12022: 32023: 12024: 12025: 32026: 1
2018high 3 (2022) · low 0 (2019)2026

Most influential descendants

Showing 5 of 11 · See all
  • K200869Gamma3 SystemStryker Trauma GmbH · 2020 · cites it directly9descendants
  • K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 2 generations on3descendants
  • K242247ARIX Femur Nail SystemJeil Medical Corporation · 2025 · 2 generations on1descendant
  • K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc. · 2026 · 2 generations on0descendants
  • K252826ARIX Femur Nail SystemJeil Medical Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−4K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa)1997—
−3K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.200154
−2K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.2003—
−1K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…Zimmer, Inc.200916
0 (this device)K172114Zimmer Natural Nail SystemZimmer, Inc.2017—
+1K200869Gamma3 SystemStryker Trauma GmbH2020—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH20221
+2K242247ARIX Femur Nail SystemJeil Medical Corporation2025—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.2026—
+2K252826ARIX Femur Nail SystemJeil Medical Corporation2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199620
199710
199820
200120
200220
200410
200510
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202230
202310
202410
202530
202610
FIG. 1 — Lineage of K172114, 1997–2026Source: 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
*K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
Summary page 5
… HSB– Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020) Predicate Device(s): K083497 Zimmer Natural Nail Zimmer Inc. System Piriformis…
Zimmer, Inc.200916
*K101622Zimmer Natural Nail System Retrograde Femoral Nails
Summary page 5
…Trochanter Antegrade Femoral Nails K101622 Zimmer Natural Zimmer Inc. System Retrograde…
Zimmer, Inc.20103

Also cleared against K083497: 6 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K200869Gamma3 SystemStryker Trauma GmbH20209
K181375Apex Femoral Nailing SystemOrthoxel20180

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 4 companies; a new generation was cleared every 4.1 years on median.
  • 11 of the 18 ancestors have a recall of any class.
  • Of its descendants, K200869 (Stryker Trauma GmbH, 2020) has gone furthest, with 9 descendants of its own.
  • 6 other devices also cite its predicate K083497.

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. 2017, 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?

ANTEGRADE FEMORAL NAILS: The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa nails in the femur include: * Compound and simple shaft fractures * Proximal, metaphyseal and distal shaft fractures * Segmental fractures * Comminuted fractures * Fractures involving osteopenic and osteoporotic bone * Pathological fractures * Fractures with…

Read the full statement (184 words)

ANTEGRADE FEMORAL NAILS:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Greater Trochanter and Piriformis Fossa nails in the femur include:

* Compound and simple shaft fractures

* Proximal, metaphyseal and distal shaft fractures

* Segmental fractures

* Comminuted fractures

* Fractures involving osteopenic and osteoporotic bone

* Pathological fractures

* Fractures with bone loss

* Pseudoarthrosis, non-union, mal-union and delayed union

* Periprosthetic fractures

* Surgically created defects such as osteotomies

* Intertrochanteric and subtrochanteric fractures

RETROGRADE FEMORAL NAILS:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the retrograde femoral nails in the femur include:

* Compound and simple shaft fractures

* Proximal, metaphyseal and distal shaft fractures

* Segmental fractures

* Closed supracondylar fractures

* Severely comminuted supracondylar fractures with articular involvement

* Fractures involving femoral condyles

* Comminuted fractures

* Fractures involving osteopenic and osteoporotic bone

* Pathological fractures

* Fractures with bone loss

* Pseudoarthrosis, non-union, and mal-union

* Periprosthetic fractures

* Poly trauma patients

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 K083497

6 other devices cite the same predicate.

  • K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 202417 recalls
  • K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
  • K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018
  • K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
  • K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 20095 recalls
  • K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 200916 recalls

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

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/K172114 · printed Nov 4, 2026

Cite this page

510(k) Report. “K172114: Zimmer Natural Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172114

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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