# K150456: Arthrex Plates, Screws, and Staples

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Apr 29, 2015 after 68 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: 9 generations back to K000684 (2000). 59 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014155: Opening/Closing Wedge Ostetomy Plates, Arthrex, Inc. (2002) Summary page 4.
- K041965: Arthrex Humeral Fracture Plates and Screws, Arthrex, Inc. (2004) Summary page 4.
- K080111: Arthrex Compression Staple, Arthrex, Inc. (2008) Summary page 4.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011) Summary page 4.
- K130510: Arthrex Compression Plates, Arthrex, Inc. (2013) Summary page 4.
- K131474: Arthrex Distal Radius Plate System, Arthrex, Inc. (2013) Summary page 4.
- K132217: Arthrex Compression FT Screws, Arthrex, Inc. (2013) Summary page 4.

## Most influential descendants
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own
- K222267: Arthrex 2.4 mm Volar Distal Radius Plate System (2022), 1 descendant of its own
- K262618: Arthrex Spine Compression FT Screw (2026), 0 descendants of its own
- K252807: Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (2026), 0 descendants of its own
- K243368: Montblanc Plate System (2025), 0 descendants of its own

## Indications for use
The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization. The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus. The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodesis 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. The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone. The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand and wrist, such as opening wedge osteotomies of Hallux Valgus. The Arthrex Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions. This system can be used for palmar, dorsal or orthogonal application. The Arthrex Compression FT Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Osteochondral fragments (talar vault, femoral condyle); Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal); Cancellous fragments (talus); Carpal, metacarpal, and small hand bone; Tarsal and metatarsals; Phalanges; Intra-articular fractures; Ankle; Proximal and distal humerus; Proximal and distal radius; Proximal and distal ulna; Osteochondral fixation and fractures; Osteochondritis Dissecans; Fixation of fractures and osteotomies about the knee; Oblique fractures of the fibula; Reconstructive surgeries of the foot; Malleolar fixation

Source page: https://510kreport.com/device/K150456
Methodology: https://510kreport.com/methodology