510(k) · Cleared
ClearedMedline UNITE® Ankle Fusion Plating System
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 Jan 25, 2023 as substantially equivalent to K213567 (Medline Industries, LP, 2022) and 3 other predicates after a 141-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Jan 25, 2023
- Review
- 141 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K954385 (1996). 187 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK222665 Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 12 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 11 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 10 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 9 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 8 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 7 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 6 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 5 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 4 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 3 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 1 generation backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- This deviceK222665 Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −12 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −11 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −10 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −9 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −8 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −7 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −6 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −5 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −4 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −3 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −1 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| 0 (this device) | K222665 | Medline UNITE® Ankle Fusion Plating System | Medline Industries, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 17 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 15 | 0 |
| 2006 | 14 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K213567 | Medline UNITE Calcaneal Fracture Plating SystemSummary page 4…Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Primary Predicate Device Medline UNITE® Calcaneal Fracture Plating System K213567 Predicate Device ORTHOLOC 3 Di Ankle Fusion Plating System K121425 001 ===… | 2022 |
| * | K121425 | Ortholoc 3DI Ankle Fusion Plating SystemSummary page 4…8.3030 and 21 CFR 888.3040 Primary Predicate Device Medline UNITE® Calcaneal Fracture Plating System K213567 Predicate Device ORTHOLOC 3 Di Ankle Fusion Plating System K121425 001 Medline Industries, LP… | 2012 |
| * | K151235 | Medline Foot Plates and ScrewsSummary page 5…K222665 Three Lakes Drive Northfield, IL 60093 Predicate Device Medline Foot Plates and Screws K151235 Predicate Device Paragon28 ParaLock Plating System K140397 Device Description The Medline UNITE® Ankle Fusion Plating System Pl… | 2015 |
| * | K140397 | Paralock Plating System / Tuffnek ScrewSummary page 5…Three Lakes Drive Northfield, IL 60093 Predicate Device Medline Foot Plates and Screws K151235 Predicate Device Paragon28 ParaLock Plating System K140397 Device Description The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6Al… | 2014 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 43 of the 187 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. 2023, 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® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles. The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material.…
Read the full statement (173 words)
The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion 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. The system can be used in both adult and pediatric (adolescent and child) patients.
Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws, which span an active growth plate in a pediatric patient, should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222665: Medline UNITE® Ankle Fusion 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/K222665
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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