510(k) · Cleared
ClearedMemory Staple (20 Sizes Available)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Landos, Inc. · JDR Staple, Fixation, Bone
Cleared on Aug 5, 1997 after a 286-day review. The FDA summary names its predicate without a number. 285 later devices descend from it.
- Decided
- Aug 5, 1997
- Review
- 286 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
285 later devices descend from it, 7 citing it directly.
- This deviceK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- Descendant · cites it directly · 222 of its ownK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- Descendant · cites it directly · 119 of its ownK991482 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 · cites it directly · 114 of its ownK070031 Memometal Memory StaplesMemometal Technologies · 2007
- Descendant · 2 generations on · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
Showing 5 of 285 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 285 · See all- K993714Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000 · cites it directly222descendants
- K991482Uni-Clip StapleNew Deal, S.A. · 1999 · cites it directly119descendants
- K011716The Uni-Clip StapleNew Deal, S.A. · 2001 · cites it directly117descendants
- K070031Memometal Memory StaplesMemometal Technologies · 2007 · cites it directly114descendants
- K061594Large Uni-Clip StapleNew Deal, S.A. · 2006 · 2 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| +1 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| +1 | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| +1 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| +1 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| +2 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 24 | 0 |
| 2015 | 22 | 0 |
| 2016 | 14 | 0 |
| 2017 | 26 | 0 |
| 2018 | 16 | 0 |
| 2019 | 18 | 0 |
| 2020 | 23 | 0 |
| 2021 | 18 | 0 |
| 2022 | 18 | 0 |
| 2023 | 25 | 0 |
| 2024 | 17 | 0 |
| 2025 | 13 | 0 |
| 2026 | 15 | 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? (3)
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 |
|---|---|---|---|
| * | — | Landos Standard Staple Named without a submission number | |
| * | — | Stryker Osteoclasp Named without a submission number | |
| * | — | Mitek Anchor II™ Named without a submission number |
What descends from it? (285)
See all 2857 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993714 | Memograph Staple, Warm System | 2000 | 222 |
| K991482 | Uni-Clip Staple | 1999 | 119 |
| K011716 | The Uni-Clip Staple | 2001 | 117 |
| K070031 | Memometal Memory Staples | 2007 | 114 |
| K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | 2007 | 72 |
| K060746 | Memory Staple | 2006 | 59 |
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
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, K993714 (Biomedical Ent., Inc., 2000) has gone furthest, with 222 descendants of its own.
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?
The Memory Staple is intended for bone fixation for the indications of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot
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/K964226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964226: Memory Staple (20 Sizes Available).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964226
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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