510(k) Report

510(k) · Cleared

Cleared

Eis Dynamic Memory Staples System

K991962510(k) TraditionalCleared Jan 10, 2000214-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

Groupe Lepine · JDR Staple, Fixation, Bone

Cleared on Jan 10, 2000 after a 214-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 118 later devices descend from it.

Decided
Jan 10, 2000
Review
214 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2012: 3 descendants cleared2019: 9 descendants cleared2016: 6 descendants cleared2017: 11 descendants cleared2022: 8 descendants cleared2011: 1 descendant cleared2009: 1 descendant cleared2024: 12 descendants cleared2023: 13 descendants cleared2020: 13 descendants cleared2015: 6 descendants cleared2014: 3 descendants cleared2018: 5 descendants cleared2021: 9 descendants cleared2025: 7 descendants cleared2026: 7 descendants cleared200020052010201520202025
  1. This deviceK991962 Eis Dynamic Memory Staples SystemGroupe Lepine · 2000
  2. Descendant · cites it directly · 117 of its ownK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
  3. Descendant · 2 generations on · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
  4. Descendant · 3 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
  5. Descendant · 4 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
  6. Descendant · 5 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

2001: 12006: 12007: 22009: 12011: 12012: 32014: 32015: 62016: 62017: 112018: 52019: 92020: 132021: 92022: 82023: 132024: 122025: 72026: 7
2001high 13 (2020) · low 0 (2002)2026

Most influential descendants

Showing 5 of 118 · See all
  • K011716The Uni-Clip StapleNew Deal, S.A. · 2001 · cites it directly117descendants
  • K061594Large Uni-Clip StapleNew Deal, S.A. · 2006 · 2 generations on103descendants
  • K070447Newdeal Compression PlateNewdeal Sas · 2007 · 3 generations on102descendants
  • K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 4 generations on98descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 5 generations on97descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991962Eis Dynamic Memory Staples SystemGroupe Lepine2000—
+1K011716The Uni-Clip StapleNew Deal, S.A.20011
+2K061594Large Uni-Clip StapleNew Deal, S.A.2006—
+3K070447Newdeal Compression PlateNewdeal Sas20072
+4K093914Newdeal Compression PlatesNewdeal Sas20115
+5K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200610
200720
200910
201110
201230
201430
201560
201660
2017110
201850
201990
2020130
202190
202280
2023130
2024120
202570
202670
FIG. 1 — Lineage of K991962, 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 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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (118)

See all 118

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

NumberDeviceApplicantDecidedDescendants
K011716The Uni-Clip StapleNew Deal, S.A.2001117

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, K011716 (New Deal, S.A., 2001) has gone furthest, with 117 descendants of its own.

How does its category compare?

All JDR devices

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

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy.

The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.

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 fracture.

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

  • K991964Eis Threaded Screw Fracture FixationGroupe Lepine · 1999

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K991962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991962: Eis Dynamic Memory Staples System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991962

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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