510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Ebi Trochanteric Nail System

K050118510(k) TraditionalCleared Feb 16, 200529-day reviewClass II21 CFR 888.3020Recalls 3

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

Ebi, L.P. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 16, 2005 as substantially equivalent to K983641 (Biomet, Inc., 1998) after a 29-day review. Its family tree reaches back 1 generation to 1998. 7 later devices descend from it. It has been recalled 3 times.

Decided
Feb 16, 2005
Review
29 days
Class
Class II
Product code
HSB
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K983641 (1998). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant clearedK983641 · Holland Femoral Nail System · Biomet, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K983641 · Holland Femoral Nail System · Biomet, Inc. · 19980
  1. Root · 1 generation backK983641 Holland Femoral Nail SystemBiomet, Inc. · 1998
  2. This deviceK050118 Ebi Trochanteric Nail SystemEbi, L.P. · 2005
  3. Descendant · cites it directly · 6 of its ownK120148 Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012
  4. Descendant · 2 generations on · 4 of its ownK202099 AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020
  5. Descendant · 2 generations on · 2 of its ownK133081 Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial…Advanced Orthopaedic Solutions, Inc. · 2013
  6. Descendant · 3 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
  7. Descendant · 3 generations on · 0 of its ownK252025 Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12020: 12023: 12025: 22026: 1
2012high 2 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc. · 2012 · cites it directly6descendants
  • K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc. · 2020 · 2 generations on4descendants
  • K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc. · 2013 · 2 generations on2descendants
  • K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 3 generations on1descendant
  • K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983641Holland Femoral Nail SystemBiomet, Inc.1998—
0 (this device)K050118Ebi Trochanteric Nail SystemEbi, L.P.2005—
+1K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.2012—
+2K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.2020—
+2K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails…Advanced Orthopaedic Solutions, Inc.2013—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.2023—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
202010
202310
202520
202610
FIG. 1 — Lineage of K050118, 1998–2026Source: 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? (1)

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
*K983641Holland Femoral Nail System
Summary page 1
…21 CFR 888.3020. 3. Predicate or legally marketed device that is substantially equivalent: Biomet Holland Femoral Nail System (K983641) 4. Description of the device: The EBI®'Trochanteric Nail System is an interlocking intramedullary rod used in the fixatio…
Biomet, Inc.1998—

Also cleared against K983641: 2 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 1, 2016Class IIZ-1819-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…
Mar 30, 2012Not classifiedZ-1478-2012Labeling mix-upsThe Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation
Jun 24, 2005Not classifiedZ-0012-06OtherUpon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K120148 (Advanced Orthopaedic Solutions, Inc., 2012) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K983641.

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 EBC® Trochanteric Nail is indicated for the treatment of fractures of the femur including: non-comminuted and comminuted midshaft fracture, subtrochanteric fracture, distal third fracture, combination fractures of the shaft and neck, intertrochanteric fracture, combination intertrochanteric and subtrochanteric fractures. The EBI Trochanteric Nail is also indicated for osteotornies. reconstructive procedures following tumor resection, revision procedures where other treatment or devices have failed, and arthrodesis.

Indications for use as stated in the FDA summary.

Also cleared against K983641

2 other devices cite the same predicate.

  • K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009
  • K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 20078 recalls

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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/K050118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050118: Ebi Trochanteric 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/K050118

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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