510(k) · Cleared
ClearedMedline Unite Mini Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · HRS Plate, Fixation, Bone
Cleared on Nov 1, 2018 as substantially equivalent to K090692 (Wrightmedicaltechnologyinc, 2009) and 2 other predicates after a 115-day review. Its family tree reaches back 11 generations to 1996. 2 later devices descend from it.
- Decided
- Nov 1, 2018
- Review
- 115 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K954385 (1996). 59 ancestors in all, the oldest K895117 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- This deviceK181820 Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK250935 TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed…TriMed, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK221360 Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP · 2022
Show all 11 generations
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 9 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 8 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 7 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 6 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 5 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 4 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- This deviceK181820 Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018
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 |
|---|---|---|---|---|---|
| −11 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −10 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −9 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −8 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −7 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −6 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −5 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −3 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −2 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 | — |
| 0 (this device) | K181820 | Medline Unite Mini Plates and Screws | Medline Industries, Inc. | 2018 | — |
| +1 | K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth… | TriMed, Inc. | 2025 | — |
| +1 | K221360 | Medline UNITE® Medial Malleolus Peg Plate System | Medline Industries, LP | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K090692 | Ortholoc 2.0/2.4 Plate SystemSummary page 4…ion Bone Classification Panel: Orthopedics Regulatory Class: II Regulation #: 21 CFR 888.3030 Primary Predicate Device ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4 Screw K090692 Predicate Devices Medline Foot Plates and Screws K151235… | 2009 |
| * | K151235 | Medline Foot Plates and ScrewsSummary page 4…s: II Regulation #: 21 CFR 888.3030 Primary Predicate Device ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4 Screw K090692 Predicate Devices Medline Foot Plates and Screws K151235 K181820… | 2015 |
| * | K130319 | Medline Cannulated ScrewSummary page 5…K181820 Page 2 of 4 Medline Cannulated Screw K130319 Reference Device Monster Screw System K151418 Device Description The Medline Unite® Mini Plates and Screws are manufactured fr… | 2013 |
| † | K151418 | Monster Screw System | 2015 |
What descends from it? (2)
2 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 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 15 of the 59 ancestors have a recall of any class.
- Of its descendants, K250935 (TriMed, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K090692.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Medline Unite® Mini Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include: • Metatarsal or metacarpal fractures and osteotomies • Cuboid fractures • Navicular fractures • Talar neck fractures • Jones and avulsion fractures of the 5th…
Read the full statement (133 words)
The Medline Unite® Mini Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures,
joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in
both adult and pediatric patients.
Examples include:
• Metatarsal or metacarpal fractures and osteotomies
• Cuboid fractures
• Navicular fractures
• Talar neck fractures
• Jones and avulsion fractures of the 5th metatarsal
• Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
•Phalanges fractures and osteotomies
The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the
same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis,
joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181820: Medline Unite Mini Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181820
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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