510(k) Report

510(k) · Cleared

Cleared

Ebi Xfix Rail System

K021031510(k) TraditionalCleared May 16, 200248-day reviewClass II21 CFR 888.3030

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

Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 16, 2002 as substantially equivalent to K991941 (Electro-Biology, Inc., 1999) and 5 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1999. 8 later devices descend from it.

Decided
May 16, 2002
Review
48 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K993886 (1999). 7 ancestors in all, the oldest K991941 (1999). 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor2003: 1 descendant cleared2013: 1 descendant cleared2008: 1 descendant cleared2019: 1 descendant cleared2005: 1 descendant cleared2011: 1 descendant cleared2020: 2 descendants clearedK993886 · Ebi Xfix Vision Fixation System · Ebi, L.P. · 1999K011711 · Modification to Ebi Efix Vision Fixation System · Ebi, L.P. · 2001K014194 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K014194 · Modification to Ebi Xfix Vision Fixation System · Ebi, L.P. · 2002K011711 · Modification to Ebi Efix Vision Fixation System · Ebi, L.P. · 2001K993886 · Ebi Xfix Vision Fixation System · Ebi, L.P. · 19990
  1. Root · 3 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
  2. 2 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
  3. 1 generation backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
  4. This deviceK021031 Ebi Xfix Rail SystemEbi, L.P. · 2002
  5. Descendant · cites it directly · 4 of its ownK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
  6. Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
  7. Descendant · cites it directly · 2 of its ownK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
  8. Descendant · 3 generations on · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
  9. Descendant · 3 generations on · 0 of its ownK193617 Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12008: 12011: 12013: 12019: 12020: 2
2003high 2 (2020) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003 · cites it directly4descendants
  • K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · cites it directly2descendants
  • K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
  • K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993886Ebi Xfix Vision Fixation SystemEbi, L.P.1999—
−2K011711Modification to Ebi Efix Vision Fixation SystemEbi, L.P.2001—
−1K014194Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.2002—
0 (this device)K021031Ebi Xfix Rail SystemEbi, L.P.2002—
+1K031875Inter-OS Limb LengthenerInter-Os Technologies2003—
+2K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.20191
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma20081
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.2020—
+3K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200810
201110
201310
201910
202020
FIG. 1 — Lineage of K021031, 1999–2020Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.4 · 14 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? (6)

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
*K991941Ebi Xfix DFS Rail System
Summary page 1
…e: Single Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of…
Electro-Biology, Inc.1999—
*K000083Ebi Xfix DFS Rail System
Summary page 1
…Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of fixation…
Ebi, L.P.20001
*K010437Modification to Ebi Xfix DFS Rail System
Summary page 1
…Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of fixation componen…
Ebi, L.P.2001—
*K993886Ebi Xfix Vision Fixation System
Summary page 1
…ces and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of fixation components and implantable bone screws. The EBI XF…
Ebi, L.P.1999—
*K014194Modification to Ebi Xfix Vision Fixation System
Summary page 1
…ccessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Ra…
Ebi, L.P.2002—
*K020141Modification to Ebi Xfix Vision Fixation System
Summary page 1
…s, 21 CFR 888.3030. 3. Predicate or Legally Marketed Devices: . EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141) 4. Description of Device: The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Rail System…
Ebi, L.P.2002—

Also cleared against K991941: 3 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K031875Inter-OS Limb LengthenerInter-Os Technologies20034
K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma20082
K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130

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 3 years and passes through 1 company; a new generation was cleared every 7 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K031875 (Inter-Os Technologies, 2003) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K991941.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

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 K991941

3 other devices cite the same predicate.

  • K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 20081 recall
  • K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003

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 KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K021031 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021031: Ebi Xfix Rail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021031

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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