510(k) · Cleared
ClearedMedline UNITE REFLEX Nitinol Staple System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · JDR Staple, Fixation, Bone
Cleared on Apr 22, 2021 as substantially equivalent to K124045 (Solana Surgical, LLC, 2013) after a 62-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.
- Decided
- Apr 22, 2021
- Review
- 62 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902307 (1990). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 1 generation backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
- This deviceK210482 Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK231885 Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP · 2023
- Descendant · cites it directly · 0 of its ownK250712 Linkt Compression Staple SystemTrax Surgical · 2025
- Descendant · 2 generations on · 0 of its ownK243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
- Descendant · cites it directly · 0 of its ownK232905 Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023
Most influential descendants
Showing 4 of 4 · See all- K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP · 2023 · cites it directly3descendants
- K250712Linkt Compression Staple SystemTrax Surgical · 2025 · cites it directly0descendants
- K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025 · 2 generations on0descendants
- K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −1 | K124045 | Fuseforce Implant System | Solana Surgical, LLC | 2013 | — |
| 0 (this device) | K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021 | — |
| +1 | K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023 | — |
| +1 | K250712 | Linkt Compression Staple System | Trax Surgical | 2025 | — |
| +2 | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025 | — |
| +1 | K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K124045 | Fuseforce Implant SystemSummary page 5…Nitinol Staples (Proposed) (Predicate) [510(k) TBD K124045 jI IProduct Owner Medline Industries, Inc. Wright Medical Technology jI… | 2013 |
What descends from it? (4)
3 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?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K231885 (Medline Industries, LP, 2023) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K124045.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Medline UNITE REFLEX Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as : LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210482 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210482: Medline UNITE REFLEX Nitinol Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210482
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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