# K021626: Hallu Plates

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Aug 12, 2002 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: 3 generations back to K000684 (2000). 10 ancestors in all.
280 later devices descend from it; 5 cite it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935448: Luhr Mini Bone Screw and Z Plate, Howmedica Corp. (1994) Summary page 2.
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 2.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000)

## Most influential descendants
- K040907: Arthrex Small Fragment Plates and Screws (2004), 249 descendants of its own
- 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
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates (2005), 92 descendants of its own

## Indications for use
The HALLUO-PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include: -Hallux rigidus -Severe hallux valgus (IM angle > 20" and HV angle > 40") -Deformity from rheumatoid arthritis -Failed previous surgical procedure -Traumatic arthritis -Neuromuscular instability

Source page: https://510kreport.com/device/K021626
Methodology: https://510kreport.com/methodology