510(k) Report

510(k) · Cleared

Cleared

X-BOLT Hip Fracture Fixation System

K181640510(k) TraditionalCleared Oct 12, 2018113-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

X-Bolt Orthopaedics · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Oct 12, 2018 as substantially equivalent to K083497 (Zimmer, Inc., 2009) and 8 other predicates after a 113-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.

Decided
Oct 12, 2018
Review
113 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
9

Its longest line of descent runs back 7 generations to K970097 (1997). 47 ancestors in all, the oldest K871539 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 2 other ancestors2005: 3 other ancestors1999: 3 other ancestors1992: 1 other ancestor1990: 2 other ancestors2004: 3 other ancestors2003: 3 other ancestors1997: 1 other ancestor1995: 2 other ancestors2002: 3 other ancestors2001: 4 other ancestors2000: 4 other ancestors1998: 5 other ancestors1996: 2 other ancestors1987: 1 other ancestor2023: 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 · recalledK091566 · Zimmer Natural Nail System Cephalomedullary Nails · Zimmer GmbH · 2009 · recalledK120715 · Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short · Zimmer GmbH · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 9 other ancestors3 generations back: 21 other ancestors4 generations back: 4 other ancestors 1 generation forward: 1 descendant K120715 · Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short · Zimmer GmbH · 2012K091566 · Zimmer Natural Nail System Cephalomedullary Nails · Zimmer GmbH · 2009 · recalledK083497 · 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 · 7 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 6 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
  3. 5 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
  4. 4 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
  5. 3 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
  6. 2 generations backK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled
  7. 1 generation backK120715 Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH · 2012
  8. This deviceK181640 X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics · 2018
  9. Descendant · cites it directly · 0 of its ownK221621 Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−6K973240Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa)1997—
−5K013563Long Trochanteric Nail SystemDePuy Orthopaedics, Inc.200154
−4K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc.2003—
−3K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…Zimmer, Inc.200916
−2K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20095
−1K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH2012—
0 (this device)K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics2018—
+1K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199020
199210
199520
199620
199710
199850
199930
200040
200140
200230
200330
200430
200530
200620
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K181640, 1997–2023Source: 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? (9)

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 4
…lass: II 5. Predicate and Reference Devices The X‐BOLT® Hip Fracture Fixation System is substantially equivalent to the Zimmer Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw…
Zimmer, Inc.200916
*K091566Zimmer Natural Nail System Cephalomedullary Nails
Summary page 4
…II 5. Predicate and Reference Devices The X‐BOLT® Hip Fracture Fixation System is substantially equivalent to the Zimmer Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (…
Zimmer GmbH20095
*K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short
Summary page 4
…II 5. Predicate and Reference Devices The X‐BOLT® Hip Fracture Fixation System is substantially equivalent to the Zimmer Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289,…
Zimmer GmbH2012—
*K050226Asian Intramedullary Hip Screw Nails
Summary page 4
…ation System is substantially equivalent to the Zimmer Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System…
Smith & Nephew, Inc.2005—
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 4
…Natural Nail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System (K062066) based on similarities in intended use, tec…
Smith & Nephew, Inc.1999—
*K921786Intramedullary Hip Screw
Summary page 4
…ail System (K083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System (K062066) based on similarities in intended use, technologica…
Smith & Nephew Richards, Inc.1992—
*K895241Intramedullary Hip Screw
Summary page 4
…083497, K091566, K120715), Smith & Nephew Asian Intramedullary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System (K062066) based on similarities in intended use, technological characteristic…
Richards Medical Co., Inc.1990—
*K062066Omega 3 System
Summary page 4
…lary Hip Screw Nails [IMHS] (K050226), Smith & Nephew Compression Hip Screw System (K993289, K921786, and K895241), and Stryker Howmedica Osteonics Omega 3 System (K062066) based on similarities in intended use, technological characteristics, and performance data. The PERI‐LOC Proximal Femur ===…
Howmedica Osteonics Corp.2006—
*K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
Summary page 5
…LOC Proximal Femur K181640 – Page 2 Locking Bone Plate System (K072818) serves as a predicate device based on similar technological characteristics and the same intended use. 6. Device Description…
Smith & Nephew, Inc.2007—

Also cleared against K083497: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230

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 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
  • 17 of the 47 ancestors have a recall of any class.
  • Of its descendants, K221621 (X-Bolt Orthopedics, 2023) has gone furthest, with 0 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. 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?

The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in: • Intertrochanteric and subtrochanteric fractures • Segmental fractures • Comminuted fractures • Pathological fractures • Fractures with bone loss • Pseudoarthrosis, non-union, mal-union, and delayed union • Surgically created defects such as osteotomies The X-BOLT®…

Read the full statement (124 words)

The X-BOLT® IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The X-BOLT® IM Hip Nailing System is indicated for use in:

• Intertrochanteric and subtrochanteric fractures

• Segmental fractures

• Comminuted fractures

• Pathological fractures

• Fractures with bone loss

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

• Surgically created defects such as osteotomies

The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis. The X-BOLT® Dynamic Hip Plating System is indicated for use in:

• Intracapsular and extracapsular fractures of the femoral neck

• Trochanteric fractures of the proximal femur

• Stable subtrochanteric fractures of the proximal femur

Indications for use as stated in the FDA summary.

Also cleared against K083497

6 other devices cite the same predicate.

  • K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 202417 recalls
  • K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018
  • K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
  • K172114Zimmer Natural Nail SystemZimmer, 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

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/K181640 · printed Nov 5, 2026

Cite this page

510(k) Report. “K181640: X-BOLT Hip Fracture Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181640

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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