510(k) · Cleared
ClearedMedline UNITE® REFLEX® Nitinol Staple Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · JDR Staple, Fixation, Bone
Cleared on Oct 19, 2023 as substantially equivalent to K231885 (Medline Industries, LP, 2023) and 2 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Oct 19, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K902307 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- 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 backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
- 2 generations backK210482 Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc. · 2021
- 1 generation backK231885 Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP · 2023
- This deviceK232905 Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023
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 | K124045 | Fuseforce Implant System | Solana Surgical, LLC | 2013 | — |
| −2 | K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021 | — |
| −1 | K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023 | — |
| 0 (this device) | 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 |
| 2013 | 2 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K231885 | Medline UNITE® REFLEX® Nitinol Staple SystemSummary page 4…DR Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 Primary Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K231885 Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K210482 Medline Industries, LP… | 2023 |
| * | K210482 | Medline UNITE REFLEX Nitinol Staple SystemSummary page 4…ion Number: 21 CFR 888.3030 Primary Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K231885 Predicate Device Medline UNITE® REFLEX® Nitinol Staple System K210482 Medline Industries, LP K23… | 2021 |
| * | K162354 | Sniper Staple SystemSummary page 5…Northfield, IL 60093 Page 2 of 6 Predicate Device Sniper Staple System K162354 Device Description The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The s… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 6 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K231885.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, 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/K232905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232905: Medline UNITE® REFLEX® Nitinol Staple Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232905
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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