# K234031: Medline UNITE Ancillary Foot Recon Plating System

- Pathway: 510(k) (Special)
- Applicant: Medline Industires, LP
- Decided: Jan 18, 2024 after 29 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: 11 generations back to K954385 (1996). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151235: Medline Foot Plates and Screws, Medline Industries, Inc. (2015) Summary page 5.
- K081374: Charlotte Lisfranc Bone Screw, Charlotte Lisfranc Plate, Wrightmedicaltechnologyinc (2008) Summary page 5.
- K130319: Medline Cannulated Screw, Medline Industries, Inc. (2013) Summary page 6.

## Most influential descendants
- K243888: Medline UNITE®  REFLEX®  Hybrid Nitinol Implant System (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K234031
Methodology: https://510kreport.com/methodology