# K151235: Medline Foot Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Aug 6, 2015 after 87 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954385 (1996). 56 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121651: Ortholoc 3DI Midfoot/Flatfoot System, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K120359: Ortholoc 3DI Hallux System, Wrightmedicaltechnologyinc (2012) Summary page 6.
- K120802: Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone Screws, Wrightmedicaltechnologyinc (2012) Summary page 6.
- (no number) ORTHOLOC™ 3Di Ankle Plating System: named in the summary without a submission number

## Most influential descendants
- K181820: Medline Unite Mini Plates and Screws (2018), 2 descendants of its own
- K234031: Medline UNITE Ancillary Foot Recon Plating System (2024), 1 descendant of its own
- K202959: PolyLock Plating System (2020), 1 descendant of its own
- K162829: Medline UNITE® Ankle Fracture Plating System (2016), 1 descendant of its own
- K250935: TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K151235
Methodology: https://510kreport.com/methodology