510(k) · Cleared
ClearedMedline UNITE® Ankle Fracture 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 Dec 9, 2016 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 5 other predicates after a 63-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Dec 9, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K954385 (1996). 61 ancestors in all, the oldest K895117 (1990). 1 later device descends from it, 1 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 deviceK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
- 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 deviceK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP · 2022 · cites it directly0descendants
View 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) | K162829 | Medline UNITE® Ankle Fracture Plating System | Medline Industries, Inc. | 2016 | — |
| +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 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 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 |
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? (6)
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 |
|---|---|---|---|
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 4…s Regulatory Class: II Regulation #: 21 CFR 888.3030 Predicate Device The following 510(k) clearance letters (Appendix C), supporting this system, have been identified: K011335 (Primary) - Synthes One Third Tubular Plate K082072 - Synthes (USA) 3.5mm LCP Hook Plate K091243 - ORTHOLOC™ Ankle Plating System… | 2001 |
| * | K082072 | Synthes (Usa) 3.5MM LCP Hook PlateSummary page 4…Predicate Device The following 510(k) clearance letters (Appendix C), supporting this system, have been identified: K011335 (Primary) - Synthes One Third Tubular Plate K082072 - Synthes (USA) 3.5mm LCP Hook Plate K091243 - ORTHOLOC™ Ankle Plating System K102429 - ORTHOLOC™ 3Di Ankle Plating System and OR… | 2008 |
| * | K091243 | Ortholoc Ankle Plating System (Aps)Summary page 4…ance letters (Appendix C), supporting this system, have been identified: K011335 (Primary) - Synthes One Third Tubular Plate K082072 - Synthes (USA) 3.5mm LCP Hook Plate K091243 - ORTHOLOC™ Ankle Plating System K102429 - ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC Bone Screws… | 2009 |
| * | K102429 | Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewSummary page 4…s system, have been identified: K011335 (Primary) - Synthes One Third Tubular Plate K082072 - Synthes (USA) 3.5mm LCP Hook Plate K091243 - ORTHOLOC™ Ankle Plating System K102429 - ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC Bone Screws K162829… | 2010 |
| * | K151235 | Medline Foot Plates and ScrewsSummary page 5…Page 2/3 Medline Industries, Inc. One Medline Place Mundelein, IL 60060 K151235 – Medline Foot Plates and Screws K130319 – Medline Cannulated Screws Device Description Medline UNITE® Ankle Fracture Plating Sy… | 2015 |
| * | K130319 | Medline Cannulated ScrewSummary page 5…Page 2/3 Medline Industries, Inc. One Medline Place Mundelein, IL 60060 K151235 – Medline Foot Plates and Screws K130319 – Medline Cannulated Screws Device Description Medline UNITE® Ankle Fracture Plating System are manufactured from Titanium Alloy… | 2013 |
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 |
|---|---|---|---|
| K221360 | Medline UNITE® Medial Malleolus Peg Plate System | 2022 | 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 6 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 61 ancestors have a recall of any class.
- Of its descendants, K221360 (Medline Industries, LP, 2022) has gone furthest, with 0 descendants of its own.
- 42 other devices also cite its predicate K011335.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® Ankle Fracture Plates and Screws are intended for fixation of fractures, osteotomies and nonunions of the distal tibia and fibula such as: • Lateral Malleolar Fractures • Syndesmosis Injuries • Medial Malleolar Fractures • Bi-Malleolar Fractures • Tri-Malleolar Fractures • Posterior Malleolar Fractures • Distal Anterior Tibia Fractures • Vertical Shear Fractures of the Medial Malleolous • Pilon Fractures • Distal Tibia Shaft Fractures •…
Read the full statement (136 words)
Medline UNITE® Ankle Fracture Plates and Screws are intended for fixation of fractures, osteotomies and nonunions of
the distal tibia and fibula such as:
• Lateral Malleolar Fractures
• Syndesmosis Injuries
• Medial Malleolar Fractures
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolous
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures
The Medline Locking and Non-Locking Cortical and Cancellous Screws are indicated for use with the Medline Ankle
Fracture 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/K162829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162829: Medline UNITE® Ankle Fracture Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162829
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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