510(k) · Cleared
ClearedMedline UNITE REFLEX Dynamic Discs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · HTN Washer, Bolt Nut
Cleared on Dec 10, 2021 as substantially equivalent to K130319 (Medline Industries, Inc., 2013) after a 198-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Dec 10, 2021
- Review
- 198 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082320 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
- 1 generation backK130319 Medline Cannulated ScrewMedline Industries, Inc. · 2013
- This deviceK211612 Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
Most influential descendants
Showing 1 of 1 · See all- K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082320 | Darco Small Screw | Wrightmedicaltechnologyinc | 2008 | — |
| −1 | K130319 | Medline Cannulated Screw | Medline Industries, Inc. | 2013 | — |
| 0 (this device) | K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | 2021 | — |
| +1 | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 |
|---|---|---|---|
| * | K130319 | Medline Cannulated ScrewSummary page 4…Nut Product Code: HTN Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 Primary Predicate Device Medline Cannulated Screws K130319 Reference Device Medline UNITE® REFLEX™ Nitinol Staple System K210482 K21… | 2013 |
| † | K210482 | Medline UNITE REFLEX Nitinol Staple System | 2021 |
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 |
|---|---|---|---|
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | 2025 | 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 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243888 (Medline Industries, LP, 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K130319.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211612 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211612: Medline UNITE REFLEX Dynamic Discs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211612
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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