# K040907: Arthrex Small Fragment Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 1, 2004 after 85 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: 4 generations back to K000684 (2000). 12 ancestors in all.
249 later devices descend from it; 7 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022325: Normed Titanium Osteotomy Plating System, Osteomedics, Inc. (2002) Summary page 1.
- K021626: Hallu Plates, New Deal, S.A. (2002) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 1.
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 1.

## Most influential descendants
- K052614: Low Profile Plate and Screw System (2005), 245 descendants of its own
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own

## Indications for use
The Arthrex Small Fragment Plates and Screws 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 for Hallux Valgus.

Source page: https://510kreport.com/device/K040907
Methodology: https://510kreport.com/methodology