510(k) Report

510(k) · Cleared

Cleared

Eis Threaded Screw Fracture Fixation

K991964510(k) TraditionalCleared Dec 20, 1999193-day reviewClass II21 CFR 888.3040

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

Groupe Lepine · HWC Screw, Fixation, Bone

Cleared on Dec 20, 1999 after a 193-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 93 later devices descend from it.

Decided
Dec 20, 1999
Review
193 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

93 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2025: 8 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2020: 5 descendants cleared2009: 1 descendant cleared2015: 7 descendants cleared2013: 2 descendants cleared2016: 4 descendants cleared2024: 10 descendants cleared2017: 10 descendants cleared2014: 2 descendants cleared2019: 4 descendants cleared2021: 5 descendants cleared2026: 11 descendants cleared2023: 14 descendants cleared2022: 6 descendants cleared1995200020052010201520202025
  1. This deviceK991964 Eis Threaded Screw Fracture FixationGroupe Lepine · 1999
  2. Descendant · cites it directly · 92 of its ownK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
  3. Descendant · 2 generations on · 68 of its ownK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
  4. Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  5. Descendant · 3 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  6. Descendant · 3 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12011: 12012: 22013: 22014: 22015: 72016: 42017: 102019: 42020: 52021: 52022: 62023: 142024: 102025: 82026: 11
2005high 14 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 93 · See all
  • K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005 · cites it directly92descendants
  • K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009 · 2 generations on68descendants
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on58descendants
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 3 generations on28descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 3 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991964Eis Threaded Screw Fracture FixationGroupe Lepine1999—
+1K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.2005—
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma2009—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited20142
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201110
201220
201320
201420
201570
201640
2017100
201940
202050
202150
202260
2023140
2024100
202580
2026110
FIG. 1 — Lineage of K991964, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (93)

See all 93

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

NumberDeviceApplicantDecidedDescendants
K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592

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, K050681 (TriMed, Inc., 2005) has gone furthest, with 92 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.

The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Groupe Lepine

2 FDA decisions under this applicant name. See the company

  • K991962Eis Dynamic Memory Staples SystemGroupe Lepine · 2000

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The HWC category page

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https://510kreport.com/device/K991964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991964: Eis Threaded Screw Fracture Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991964

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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