510(k) · Cleared
ClearedMedline UNITE Calcaneal Fracture Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · HRS Plate, Fixation, Bone
Cleared on Mar 2, 2022 as substantially equivalent to K142121 (Wrightmedicaltechnologyinc, 2014) after a 113-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Mar 2, 2022
- Review
- 113 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022325 (2002). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
- 2 generations backK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
- 1 generation backK142121 Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc · 2014
- This deviceK213567 Medline UNITE Calcaneal Fracture Plating SystemMedline Industries, LP · 2022
- Descendant · cites it directly · 0 of its ownK222665 Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022325 | Normed Titanium Osteotomy Plating System | Osteomedics, Inc. | 2002 | 1 |
| −2 | K061808 | Darco Locking Bone Plate System | Darco International, Inc. | 2006 | 3 |
| −1 | K142121 | Valor Hindfoot Fusion Nail System | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K213567 | Medline UNITE Calcaneal Fracture Plating System | Medline Industries, LP | 2022 | — |
| +1 | K222665 | Medline UNITE® Ankle Fusion Plating System | Medline Industries, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K142121 | Valor Hindfoot Fusion Nail SystemSummary page 4…e: HRS Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 Predicate Device Wright Medical ORTHOLOC® Calcaneal Plating System K142121 K213567 - Page 2 of 3… | 2014 |
| † | K090582 | Calcaneal Fracture Plate System | 2009 |
| † | K151235 | Medline Foot Plates and Screws | 2015 |
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 |
|---|---|---|---|
| K222665 | Medline UNITE® Ankle Fusion Plating System | 2023 | 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 20 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K222665 (Medline Industries, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142121.
How does its category compare?
All HRS devicesHRS Plate, 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 · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213567 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213567: Medline UNITE Calcaneal Fracture Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213567
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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