510(k) Report

510(k) · Cleared

Cleared

Ebi Xfix DFS System

K000319510(k) SpecialCleared Feb 25, 200023-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 Feb 25, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 700 later devices descend from it.

Decided
Feb 25, 2000
Review
23 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

700 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2008: 20 descendants cleared2003: 3 descendants cleared2010: 19 descendants cleared2007: 12 descendants cleared2014: 37 descendants cleared2015: 42 descendants cleared2016: 40 descendants cleared2011: 18 descendants cleared2013: 38 descendants cleared2023: 56 descendants cleared2005: 5 descendants cleared2012: 26 descendants cleared2018: 45 descendants cleared2009: 11 descendants cleared2006: 6 descendants cleared2004: 1 descendant cleared2019: 28 descendants cleared2017: 40 descendants cleared2020: 38 descendants cleared2024: 49 descendants cleared2022: 41 descendants cleared2021: 33 descendants cleared2025: 44 descendants cleared2026: 46 descendants cleared200020052010201520202025
  1. This deviceK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. Descendant · cites it directly · 693 of its ownK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. Descendant · 2 generations on · 579 of its ownK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. Descendant · 2 generations on · 466 of its ownK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  5. Descendant · 3 generations on · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
  6. Descendant · 3 generations on · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled

Showing 5 of 700 descendants. See all descendants

Descendants cleared per year

2002: 22003: 32004: 12005: 52006: 62007: 122008: 202009: 112010: 192011: 182012: 262013: 382014: 372015: 422016: 402017: 402018: 452019: 282020: 382021: 332022: 412023: 562024: 492025: 442026: 46
2002high 56 (2023) · low 1 (2004)2026

Most influential descendants

Showing 5 of 700 · See all
  • K020279Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · cites it directly693descendants
  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 2003 · 2 generations on579descendants
  • K024096Optima, Spinal SystemU&I Corp., America · 2003 · 2 generations on466descendants
  • K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · 3 generations on181descendants
  • K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · 3 generations on180descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000319Ebi Xfix DFS SystemEbi, L.P.2000—
+1K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
+2K031585U&I, Optima, Spinal SystemU&I Corp., America20035
+2K024096Optima, Spinal SystemU&I Corp., America20033
+3K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006—
+3K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200330
200410
200550
200660
2007120
2008200
2009110
2010190
2011180
2012260
2013380
2014370
2015420
2016400
2017400
2018450
2019280
2020380
2021330
2022410
2023560
2024490
2025440
2026460
FIG. 1 — Lineage of K000319, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (700)

See all 700

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

NumberDeviceApplicantDecidedDescendants
K020279Forex Corporation, Optima, Spinal SystemForex Corp.2002693
K021695Ebi Dynafix Diaphyseal Correction SystemEbi, L.P.20025
K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma20082

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?

  • Of its descendants, K020279 (Forex Corp., 2002) has gone furthest, with 693 descendants of its own.

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—

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

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The KTT category page

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https://510kreport.com/device/K000319 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000319: Ebi Xfix DFS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000319

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026