510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

K201346510(k) TraditionalCleared Sep 23, 2020125-day reviewClass II21 CFR 888.3020Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (USA) Products, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 23, 2020 as substantially equivalent to K033618 (Synthes (Usa), 2004) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it. It has been recalled 2 times.

Decided
Sep 23, 2020
Review
125 days
Class
Class II
Product code
HSB
Recalls
2
Predicates
2

Its longest line of descent runs back 1 generation to K000089 (2000). 2 ancestors in all. 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2025: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2026: 4 descendants clearedK000089 · Synthes 4.0 and 5.0 MM Locking Screws · Synthes (Usa) · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K000089 · Synthes 4.0 and 5.0 MM Locking Screws · Synthes (Usa) · 20000
  1. Root · 1 generation backK000089 Synthes 4.0 and 5.0 MM Locking ScrewsSynthes (Usa) · 2000
  2. This deviceK201346 DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes…Synthes (USA) Products, LLC · 2020
  3. Descendant · cites it directly · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
  4. Descendant · 2 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
  5. Descendant · cites it directly · 1 of its ownK233696 DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes · 2024
  6. Descendant · cites it directly · 1 of its ownK220659 AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022
  7. Descendant · cites it directly · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2022: 12024: 12025: 12026: 4
2022high 4 (2026) · low 0 (2023)2026

Most influential descendants

Showing 5 of 7 · See all
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · cites it directly2descendants
  • K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 2 generations on1descendant
  • K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes · 2024 · cites it directly1descendant
  • K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc. · 2022 · cites it directly1descendant
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000089Synthes 4.0 and 5.0 MM Locking ScrewsSynthes (Usa)2000—
0 (this device)K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking…Synthes (USA) Products, LLC2020—
+1K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025—
+2K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026—
+1K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes2024—
+1K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.2022—
+1K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202410
202510
202640
FIG. 1 — Lineage of K201346, 2000–2026Source: 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
*K033618Synthes (Usa) Retrograde/Antegrade Femoral Nail System
Summary page 4
…& 888.3040 Product Code: HSB, HWC Primary Predicate Devices: Synthes Retrograde/Antegrade Femoral Nail (K033618) Predicate Devices Secondary Predicate Devices: Synthes 4.0 and 5.0mm Locking Screws…
Synthes (Usa)20041
*K000089Synthes 4.0 and 5.0 MM Locking Screws
Summary page 4
…rograde/Antegrade Femoral Nail (K033618) Predicate Devices Secondary Predicate Devices: Synthes 4.0 and 5.0mm Locking Screws (K000089) The proposed Retrograde Femoral Nail Advanced System is being developed to address c…
Synthes (Usa)2000—

Also cleared against K033618: 5 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252
K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes20241
K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221
K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 26, 2025Class IIZ-0228-2026Process controlAlthough the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Sep 26, 2025Class IIZ-0229-2026Process controlAlthough the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

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, K250163 (Stryker GmbH, 2025) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate K033618.

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. 2020, 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 DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

- Supracondylar fractures, including those with intra-articular extension

- Combination of ipsilateral condylar and diaphyseal fractures

- Ipsilateral femur/tibia fractures

- Femoral fractures in multiple trauma patients

- Periprosthetic fractures

- Fractures in the morbidly obese

- Fractures in osteoporotic bone

- Impending pathologic fractures

- Malunions and nonunions

The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

Indications for use as stated in the FDA summary.

Also cleared against K033618

5 other devices cite the same predicate.

  • K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemDePuy Synthes · 2024
  • K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
  • K171108AUTOBAHN Nailing SystemGlobus Medical, Inc. · 2017
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 20111 recall
  • K091309Revolution Femoral Intramedullary Nail System, Model DgooxxDgimed Ortho, Inc. · 2009

More from Synthes (USA) Products, LLC

45 FDA decisions under this applicant name. See the company

  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K212943SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
  • K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021
  • K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC · 2021
  • K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemSynthes (USA) Products, LLC · 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/K201346 · printed Nov 3, 2026

Cite this page

510(k) Report. “K201346: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201346

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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