510(k) Report

510(k) · Cleared

Recalled · Class III · 2017

The Uni-Clip Staple

K011716510(k) TraditionalCleared Aug 30, 200187-day reviewClass II21 CFR 888.3030Recalls 1

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 Aug 30, 2001 as substantially equivalent to K991482 (New Deal, S.A., 1999) and 4 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1997. 117 later devices descend from it. It has been recalled once.

Decided
Aug 30, 2001
Review
87 days
Class
Class II
Product code
JDR
Recalls
1
Predicates
5

Its longest line of descent runs back 2 generations to K964226 (1997). 6 ancestors in all, the oldest K895117 (1990). 117 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1990: 2 other ancestors2006: 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 clearedK964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 1997K991482 · Uni-Clip Staple · New Deal, S.A. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 13 descendants7 generations forward: 31 descendants8 generations forward: 22 descendants9 generations forward: 15 descendants10 generations forward: 8 descendants11 generations forward: 5 descendants12 generations forward: 1 descendant K991482 · Uni-Clip Staple · New Deal, S.A. · 1999K964226 · Memory Staple (20 Sizes Available) · Landos, Inc. · 19970+5+10
  1. Root · 2 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  2. 1 generation backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
  3. This deviceK011716 The Uni-Clip StapleNew Deal, S.A. · 2001
  4. Descendant · cites it directly · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
  5. Descendant · 2 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
  6. Descendant · 3 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
  7. Descendant · 4 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  8. Descendant · 5 generations on · 95 of its ownK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 117 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22009: 12011: 12012: 32014: 32015: 62016: 62017: 112018: 52019: 92020: 132021: 92022: 82023: 132024: 122025: 72026: 7
2006high 13 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 117 · See all
  • K061594Large Uni-Clip StapleNew Deal, S.A. · 2006 · cites it directly103descendants
  • K070447Newdeal Compression PlateNewdeal Sas · 2007 · 2 generations on102descendants
  • K093914Newdeal Compression PlatesNewdeal Sas · 2011 · 3 generations on98descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 4 generations on97descendants
  • K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012 · 5 generations on95descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964226Memory Staple (20 Sizes Available)Landos, Inc.1997—
−1K991482Uni-Clip StapleNew Deal, S.A.1999—
0 (this device)K011716The Uni-Clip StapleNew Deal, S.A.2001—
+1K061594Large Uni-Clip StapleNew Deal, S.A.2006—
+2K070447Newdeal Compression PlateNewdeal Sas20072
+3K093914Newdeal Compression PlatesNewdeal Sas20115
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
+5K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200910
201110
201230
201430
201560
201660
2017110
201850
201990
2020130
202190
202280
2023130
2024120
202570
202670
FIG. 1 — Lineage of K011716, 1997–2026Source: 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 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
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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
*K991482Uni-Clip Staple
Summary page 2
…osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) PREDICATE DEVICE: The “new” UNI-CLIP® STAPLE is substantially equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple( DePuy) (K964226), the memograph Staple (Biomedical Ent) (K993714), the EIS Dynamic Memory Staple (Groupe Lep…
New Deal, S.A.1999—
*K964226Memory Staple (20 Sizes Available)
Summary page 2
…nt (such as Scarf, Chevron, etc.) PREDICATE DEVICE: The “new” UNI-CLIP® STAPLE is substantially equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple( DePuy) (K964226), the memograph Staple (Biomedical Ent) (K993714), the EIS Dynamic Memory Staple (Groupe Lepine) (K991962), the HTO Compression s…
Landos, Inc.1997—
*K993714Memograph Staple, Warm System
Summary page 2
…CE: The “new” UNI-CLIP® STAPLE is substantially equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple( DePuy) (K964226), the memograph Staple (Biomedical Ent) (K993714), the EIS Dynamic Memory Staple (Groupe Lepine) (K991962), the HTO Compression staple (Howmedica) (K895117), or the Richards Fixa…
Biomedical Ent., Inc.2000—
*K991962Eis Dynamic Memory Staples System
Summary page 2
…t to the UNI-CLIP® STAPLE (K991482), the Memory Staple( DePuy) (K964226), the memograph Staple (Biomedical Ent) (K993714), the EIS Dynamic Memory Staple (Groupe Lepine) (K991962), the HTO Compression staple (Howmedica) (K895117), or the Richards Fixation Staples (Smith and Nephew Richards). COMPARISON OF…
Groupe Lepine2000—
*K895117Hto Compressing Staple
Summary page 2
…aple( DePuy) (K964226), the memograph Staple (Biomedical Ent) (K993714), the EIS Dynamic Memory Staple (Groupe Lepine) (K991962), the HTO Compression staple (Howmedica) (K895117), or the Richards Fixation Staples (Smith and Nephew Richards). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the UNI-CLIP®…
Howmedica Corp.1990—
*—Richards Fixation Staples (Smith and Nephew Richards)
Named without a submission number
—

Also cleared against K991482: 1 other device →

What descends from it? (117)

See all 117

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

NumberDeviceApplicantDecidedDescendants
K061594Large Uni-Clip StapleNew Deal, S.A.2006103
K112794Eos Small Bone Fixation SystemTriMed, Inc.20129
K153395OS2-C Compression StapleIn2bones Sas20167
K153622First Ray Internal Bone Staple SystemFirst Ray, LLC20164
K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC20190
K070688Nexfix Compression StapleNexa Orthopedics, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 25, 2017Class IIIZ-1410-2017Device DesignThe firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K061594 (New Deal, S.A., 2006) has gone furthest, with 103 descendants of its own.
  • 1 other device also cites its predicate K991482.

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 “new” uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:

Arthrodesis in hand or foot surgery

Mono or Bi-cortical osteotomies in the foot or hand

Fracture management in the foot or hand

Distal or proximal metatarsal or metacarpal osteotomies

Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

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 K991482

1 other device cites the same predicate.

  • K171473Compressyn™ StapleDallen Medical, Inc. · 2017

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/K011716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011716: The 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/K011716

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026