# K192356: Airlock Centrolock Osteosynthesis Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Novastep
- Decided: Dec 14, 2019 after 107 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). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120157: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 6.
- K143523: Airlock osteosynthesis plate system, Novastep (2015) Summary page 5.
- K162353: MICATM Screw System, Wrightmedicaltechnologyinc (2017) Summary page 5.

## Most influential descendants
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own

## Indications for use
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes. Examples include: * Mono or Bi-Cortical osteotomies in the foot or hand » Distal or Proximal metatarsal or metacarpal osteotomies » Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) » Calcaneus/cuboid arthrodesis + Talar/navicular arthrodesis The system may be used m adult patients.

Source page: https://510kreport.com/device/K192356
Methodology: https://510kreport.com/methodology