510(k) · Cleared
ClearedEasyClip Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restore Surgical, LLC Dba Instratek · JDR Staple, Fixation, Bone
Cleared on Feb 10, 2017 as substantially equivalent to K133523 (Instratek, Inc., 2014) and 1 other predicate after a 175-day review. Its family tree reaches back 5 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 10, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902307 (1990). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 3 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 2 generations backK122113 Memory Metal Staples, EasyclipStryker Corp. · 2013 · Recalled
- 1 generation backK133523 Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
- This deviceK162321 EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017
- Descendant · cites it directly · 1 of its ownK210582 EasyClip® and EasyClip® XpressStryker GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −4 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −3 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −2 | K122113 | Memory Metal Staples, Easyclip | Stryker Corp. | 2013 | 1 |
| −1 | K133523 | Stapix Superelastic Implant Bone Staples | Instratek, Inc. | 2014 | — |
| 0 (this device) | K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017 | — |
| +1 | K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K133523 | Stapix Superelastic Implant Bone StaplesSummary page 4…JDR Regulation/Description: 880.3030, Staple, Fixation, Bone Predicate Devices Stapix Superelastic Nitinol Fixation System (K133523) Stryker Memory Staple (K122113). Description of the device: EasyClip Xpress is… | 2014 |
| * | K122113 | Memory Metal Staples, EasyclipSummary page 4…Fixation, Bone Predicate Devices Stapix Superelastic Nitinol Fixation System (K133523) Stryker Memory Staple (K122113). Description of the device: EasyClip Xpress is comprised of superelastic bone staples, as well… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210582 | EasyClip® and EasyClip® Xpress | 2022 | 1 |
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 27 years and passes through 6 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K210582 (Stryker GmbH, 2022) has gone furthest, with 1 descendant 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. 2017, 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 XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162321: 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/K162321
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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