510(k) · Cleared
ClearedMedline UNITE® Medial Malleolus Peg Plate 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 Sep 27, 2022 as substantially equivalent to K162829 (Medline Industries, Inc., 2016) and 2 other predicates after a 139-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Sep 27, 2022
- Review
- 139 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K954385 (1996). 156 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- 1 generation backK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
- This deviceK221360 Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP · 2022
Show all 12 generations
- Root · 12 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 11 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 10 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 9 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 8 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 7 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 6 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 5 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 4 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 3 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 2 generations backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- 1 generation backK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
- This deviceK221360 Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −11 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −10 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −9 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −8 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −7 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −6 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −4 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −3 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −2 | K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 | — |
| −1 | K162829 | Medline UNITE® Ankle Fracture Plating System | Medline Industries, Inc. | 2016 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 13 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K162829 | Medline UNITE® Ankle Fracture Plating SystemSummary page 4…egulatory Class: Class II Regulation Number: 21 CFR 888.3030 21 CFR 888.3040 Primary Predicate Device Medline UNITE® Ankle Fracture Plating System K162829 Page 1 of 4 K221360… | 2016 |
| * | K132502 | Variax 2 SystemSummary page 5…Page 5 === Medline Industries, LP Three Lakes Drive Northfield, IL 60093 Predicate Device Stryker VariAx 2 System K132502 Medline UNITE® Mini Plates and Screws K181820 Reference Device Medline Foot Plates and Screws K151235 Device Description The M… | 2013 |
| * | K181820 | Medline Unite Mini Plates and ScrewsSummary page 5…, LP Three Lakes Drive Northfield, IL 60093 Predicate Device Stryker VariAx 2 System K132502 Medline UNITE® Mini Plates and Screws K181820 Reference Device Medline Foot Plates and Screws K151235 Device Description The Medline UNITE® Medial Malleolar Peg Plate System… | 2018 |
| † | K151235 | Medline Foot Plates and Screws | 2015 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 29 of the 156 ancestors have a recall of any class.
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?
The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, osteotomies, and nonunions of the distal tibia and fibula such as: Medial Malleolar Fractures Lateral Malleolar Fractures Syndesmosis Injuries Bi-Malleolar Fractures Tri-Malleolar Fractures Vertical Shear Fractures of the Medial Malleolus Medial Malleolar Avulsion Fractures Lateral…
Read the full statement (124 words)
The Medline UNITE® Medial Malleolus Peg Plate System, when used in conjunction with the Medline UNITE® Locking and Non-Locking Screws, are indicated for fixation of fractures, osteotomies, and nonunions of the distal tibia and fibula such as:
Medial Malleolar Fractures
Lateral Malleolar Fractures
Syndesmosis Injuries
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Vertical Shear Fractures of the Medial Malleolus
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avulsion Fractures
In addition, the Medline UNITE® Locking Pegs, when used in conjunction with the Medline UNITE® Mini Plates and Screws, are indicated 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 (adolescent and child) patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221360: Medline UNITE® Medial Malleolus Peg Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221360
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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