510(k) · Cleared
ClearedEasyClip® and EasyClip® Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · JDR Staple, Fixation, Bone
Cleared on Jun 10, 2022 as substantially equivalent to K122113 (Stryker Corp., 2013) and 1 other predicate after a 469-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Jun 10, 2022
- Review
- 469 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902307 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 5 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 4 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 3 generations backK122113 Memory Metal Staples, EasyclipStryker Corp. · 2013 · Recalled
- 2 generations backK133523 Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
- 1 generation backK162321 EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017
- This deviceK210582 EasyClip® and EasyClip® XpressStryker GmbH · 2022
- Descendant · cites it directly · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −5 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −4 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −3 | K122113 | Memory Metal Staples, Easyclip | Stryker Corp. | 2013 | 1 |
| −2 | K133523 | Stapix Superelastic Implant Bone Staples | Instratek, Inc. | 2014 | — |
| −1 | K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017 | — |
| 0 (this device) | K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022 | — |
| +1 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K122113 | Memory Metal Staples, EasyclipSummary page 5…Fax: +41 32 641 66 60 Date: June 10, 2022 Primary Predicate Device: EasyClip® (Memory Metal Staples) - K122113 Additional Predicate Device: EasyClip® Xpress - K162321 Device Description: The EasyClip® & EasyClip®… | 2013 |
| * | K162321 | EasyClip XpressSummary page 5…June 10, 2022 Primary Predicate Device: EasyClip® (Memory Metal Staples) - K122113 Additional Predicate Device: EasyClip® Xpress - K162321 Device Description: The EasyClip® & EasyClip® Xpress, previously cleared in K122113 and… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241932 | OSSIOfiber® Compression Staple | 2024 | 0 |
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 32 years and passes through 7 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K241932 (OSSIO, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K122113.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 EasyClip® staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
The EasyClip® Xpress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210582: EasyClip® and EasyClip® Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210582
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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