510(k) · Cleared
ClearedMedline Foot 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 Aug 6, 2015 as substantially equivalent to K121651 (Wrightmedicaltechnologyinc, 2012) and 2 other predicates after an 87-day review. Its family tree reaches back 10 generations to 1996. 10 later devices descend from it.
- Decided
- Aug 6, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K954385 (1996). 56 ancestors in all, the oldest K895117 (1990). 10 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK181820 Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
- Descendant · cites it directly · 1 of its ownK202959 PolyLock Plating SystemFusion Orthopedics, LLC · 2020
- Descendant · cites it directly · 1 of its ownK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK250935 TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed…TriMed, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 8 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 7 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 6 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 5 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 4 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018 · cites it directly2descendants
- K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024 · cites it directly1descendant
- K202959PolyLock Plating SystemFusion Orthopedics, LLC · 2020 · cites it directly1descendant
- K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016 · cites it directly1descendant
- K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −9 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −8 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −7 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −6 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −5 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −3 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −2 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −1 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| 0 (this device) | K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 | — |
| +1 | K181820 | Medline Unite Mini Plates and Screws | Medline Industries, Inc. | 2018 | — |
| +1 | K234031 | Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP | 2024 | — |
| +1 | K202959 | PolyLock Plating System | Fusion Orthopedics, LLC | 2020 | — |
| +1 | K162829 | Medline UNITE® Ankle Fracture Plating System | Medline Industries, Inc. | 2016 | — |
| +2 | K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth… | TriMed, Inc. | 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 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K121651 | Ortholoc 3DI Midfoot/Flatfoot SystemSummary page 4…Product Code: HRS: Plate, Fixation, Bone HWC: Screw, Fixation Bone Classification Panel: Orthopedics Predicate Device WRIGHT MEDICAL ORTHOLOC™ 3Di System K121651 (Primary) – ORTHOLOC™ 3Di Midfoot/Flatfoot System (Wright Midfoot/Flatfoot System)… | 2012 |
| * | K120359 | Ortholoc 3DI Hallux SystemSummary page 6…cal Characteristics The proposed device is substantially equivalent to the predicate devices. The Wright Medical ORTHOLOC™ 3Di System K121651, ORTHOLOC 3Di Hallux System K120359, ORTHOLOC™ 3Di Ankle Plating System and the Ortholoc Bone Screws K120802 were selected as the predicates based on the same intend… | 2012 |
| * | K120802 | Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsSummary page 6…e predicate devices. The Wright Medical ORTHOLOC™ 3Di System K121651, ORTHOLOC 3Di Hallux System K120359, ORTHOLOC™ 3Di Ankle Plating System and the Ortholoc Bone Screws K120802 were selected as the predicates based on the same intended use and same materials. Summary of Non-Clinical Testing Summary of P… | 2012 |
| * | — | ORTHOLOC™ 3Di Ankle Plating System Named without a submission number |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181820 | Medline Unite Mini Plates and Screws | 2018 | 2 |
| K234031 | Medline UNITE Ancillary Foot Recon Plating System | 2024 | 1 |
| K202959 | PolyLock Plating System | 2020 | 1 |
| K162829 | Medline UNITE® Ankle Fracture Plating System | 2016 | 1 |
| K222665 | Medline UNITE® Ankle Fusion Plating System | 2023 | 0 |
| K171690 | Trident Extremity Fixation System | 2018 | 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 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 56 ancestors have a recall of any class.
- Of its descendants, K181820 (Medline Industries, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K121651.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Foot Plates and Screws are 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…
Read the full statement (189 words)
The Medline Foot Plates and Screws are 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151235: Medline Foot 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/K151235
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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