510(k) Report

510(k) · Cleared

Cleared

Large Uni-Clip Staple

K061594510(k) SpecialCleared Jul 3, 200625-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

New Deal, S.A. · JDR Staple, Fixation, Bone

Cleared on Jul 3, 2006 as substantially equivalent to K011716 (New Deal, S.A., 2001) after a 25-day review. Its family tree reaches back 3 generations to 1997. 103 later devices descend from it.

Decided
Jul 3, 2006
Review
25 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K964226 (1997). 7 ancestors in all, the oldest K895117 (1990). 103 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1990: 2 other ancestors2007: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant cleared2017: 10 descendants cleared2012: 2 descendants cleared2020: 13 descendants cleared2022: 6 descendants cleared2015: 6 descendants cleared2014: 3 descendants cleared2019: 6 descendants cleared2016: 4 descendants cleared2023: 11 descendants cleared2018: 5 descendants cleared2024: 11 descendants cleared2021: 9 descendants cleared2025: 7 descendants cleared2026: 7 descendants clearedK964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 1997K991482 · Uni-Clip Staple · New Deal, S.A. · 1999K011716 · The Uni-Clip Staple · New Deal, S.A. · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 13 descendants6 generations forward: 31 descendants7 generations forward: 22 descendants8 generations forward: 15 descendants9 generations forward: 8 descendants10 generations forward: 5 descendants11 generations forward: 1 descendant K011716 · The Uni-Clip Staple · New Deal, S.A. · 2001 · recalledK991482 · Uni-Clip Staple · New Deal, S.A. · 1999K964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 19970+5+10
  1. Root · 3 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  2. 2 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
  3. 1 generation backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
  4. This deviceK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
  5. Descendant · cites it directly · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
  6. Descendant · 2 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
  7. Descendant · 3 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  8. Descendant · 4 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  9. Descendant · 5 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12011: 12012: 22014: 32015: 62016: 42017: 102018: 52019: 62020: 132021: 92022: 62023: 112024: 112025: 72026: 7
2007high 13 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 103 · See all
  • K070447Newdeal Compression PlateNewdeal Sas · 2007 · cites it directly102descendants
  • K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 2 generations on98descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 3 generations on97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 4 generations on95descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 5 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K964226Memory Staple (20 Sizes Available)Landos, Inc.1997—
−2K991482Uni-Clip StapleNew Deal, S.A.1999—
−1K011716The Uni-Clip StapleNew Deal, S.A.20011
0 (this device)K061594Large Uni-Clip StapleNew Deal, S.A.2006—
+1K070447Newdeal Compression PlateNewdeal Sas20072
+2K093914Newdeal Compression PlatesNewdeal Sas20115
+3K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+4K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 282014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201110
201220
201430
201560
201640
2017100
201850
201960
2020130
202190
202260
2023110
2024110
202570
202670
FIG. 1 — Lineage of K061594, 1997–2026Source: 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 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 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? (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
*K011716The Uni-Clip Staple
Summary page 2
…indication. G. Substantial Equivalence The new LARGE UNI-CLIP® staples are substantially equivalent to commercially marketed device, UNI-CLIP® staples, K01 1716. H. Comparison of Technological Characteristics The modified device has the same fundamental scientific technology and…
New Deal, S.A.20011

Also cleared against K011716: 5 other devices →

What descends from it? (103)

See all 103

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

NumberDeviceApplicantDecidedDescendants
K070447Newdeal Compression PlateNewdeal Sas2007102

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 9 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K070447 (Newdeal Sas, 2007) has gone furthest, with 102 descendants of its own.
  • 5 other devices also cite its predicate K011716.

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 LARGE UNI-CLIP® is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

- Arthrodesis in hand or foot surgery

- Fractures management in the foot or hand

- Mono or Bi-cortical osteotomies in the foot or hand

- Distal or proximal metatarsal or metacarpal osteotomies

- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of staple(s) used should be adapted to the specific indication.

Indications for use as stated in the FDA summary.

Also cleared against K011716

5 other devices cite the same predicate.

  • K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC · 2019
  • K153622First Ray Internal Bone Staple SystemFirst Ray, LLC · 2016
  • K153395OS2-C Compression StapleIn2bones Sas · 2016
  • K112794Eos Small Bone Fixation SystemTriMed, Inc. · 20124 recalls
  • K070688Nexfix Compression StapleNexa Orthopedics, Inc. · 2007

More from New Deal, S.A.

28 FDA decisions under this applicant name. See the company

  • K070160Modification to TTC PlatesNew Deal, S.A. · 2007
  • K063820Lisfranc PlateNew Deal, S.A. · 2007
  • K070241Modification to Lapidus PlateNew Deal, S.A. · 20071 recall
  • K060474Lisfranc PlateNew Deal, S.A. · 2006
  • K061765Kalix II ImplantNew Deal, S.A. · 2006

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/K061594 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061594: Large Uni-Clip Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061594

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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