# K143523: Airlock osteosynthesis plate system

- Pathway: 510(k) (Traditional)
- Applicant: Novastep
- Decided: Apr 6, 2015 after 115 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 K022325 (2002). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083447: Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50, Memometal Technologies (2009) Summary page 4.

## Most influential descendants
- K192356: Airlock Centrolock Osteosynthesis Implant System (2019), 2 descendants of its own
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own
- K260274: Airlock® Ankle Plating System (2026), 0 descendants of its own

## Indications for use
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand., feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K143523
Methodology: https://510kreport.com/methodology