510(k) · Cleared
ClearedUni-Clip Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · JDR Staple, Fixation, Bone
Cleared on Jun 3, 1999 as substantially equivalent to K964226 (Landos, Inc., 1997) after a 36-day review. Its family tree reaches back 1 generation to 1997. 119 later devices descend from it.
- Decided
- Jun 3, 1999
- Review
- 36 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964226 (1997). 119 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- This deviceK991482 Uni-Clip StapleNew Deal, S.A. · 1999
- Descendant · cites it directly · 117 of its ownK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- Descendant · 2 generations on · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
- Descendant · 3 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
- Descendant · 4 generations on · 98 of its ownK093914 Newdeal Compression PlatesNewdeal Sas · 2011 · Recalled
- Descendant · 5 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| 0 (this device) | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| +1 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| +2 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
| +3 | K070447 | Newdeal Compression Plate | Newdeal Sas | 2007 | 2 |
| +4 | K093914 | Newdeal Compression Plates | Newdeal Sas | 2011 | 5 |
| +5 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 13 | 0 |
| 2021 | 9 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 0 |
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 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964226 | Memory Staple (20 Sizes Available)Summary page 2…rsus varus primus ® Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot The UNI-CLIP® STAPLE is substantially equivalent to Memory Staple from DePuy, Inc.( K964226) . Both the UNI-CLIP® STAPLE have the same intended of use and all are indicated for fixing small fractures or osteotomies. All… | 1997 |
What descends from it? (119)
See all 1192 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
Mono or bi-cortical osteotomies in the forefoot
Distal or proximal metatarsal osteotomies
Fusion of the first metatarsophalongeal joint and the interphalangeal joint
Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron)
Akyn type Osteotomy
Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991482: Uni-Clip Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991482
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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