510(k) · Cleared
ClearedMedline UNITE Ancillary Foot Recon Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industires, LP · HRS Plate, Fixation, Bone
Cleared on Jan 18, 2024 as substantially equivalent to K151235 (Medline Industries, Inc., 2015) and 2 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Jan 18, 2024
- Review
- 29 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). 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 deviceK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
- Descendant · cites it directly · 0 of its ownK243888 Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
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 deviceK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
Most influential descendants
Showing 1 of 1 · See all- K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025 · 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) | K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | 2024 | — |
| +1 | K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025 | — |
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 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K151235 | Medline Foot Plates and ScrewsSummary page 5…ssification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Primary Predicate Device Medline Foot Plates and Screws K151235 Predicate Device CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate K081374… | 2015 |
| * | K081374 | Charlotte Lisfranc Bone Screw, Charlotte Lisfranc PlateSummary page 5…88.3030 and 21 CFR 888.3040 Primary Predicate Device Medline Foot Plates and Screws K151235 Predicate Device CHARLOTTE™ LisFranc Bone Screw & CHARLOTTE™ LisFranc Plate K081374 Page 1 of 6… | 2008 |
| * | K130319 | Medline Cannulated ScrewSummary page 6…K234031 Predicate Device Information Medline Cannulated Screw K130319 Device Description The Medline UNITE® Ancillary Foot Recon Plating System Plates and Screws 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 |
|---|---|---|---|
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | 2025 | 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 28 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 59 ancestors have a recall of any class.
- Of its descendants, K243888 (Medline Industries, LP, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K151235.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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® Ancillary Foot Recon Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include: • Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) • Arthrodesis of the first metatarsophalangeal joint (MTP) including: • Primary MTP Fusion due to hallux ridgidus and/or hallux valgus • Revision MTP…
Read the full statement (242 words)
The Medline UNITE® Ancillary Foot Recon Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Arthrodesis of the first metatarsophalangeal joint (MTP) including:
• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant
• Flatfoot Osteotomies:
• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• Medial Displacement Calcaneal Osteotomy (MDCO)
• Midfoot / Hindfoot Fusions:
• LisFranc Arthrodesis and/or Stabilization
• 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Medial Column Fusions (NC and 1st TMT)
The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot 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 Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234031: Medline UNITE Ancillary Foot Recon 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/K234031
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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