# K182285: PK High Tibial Osteotomy Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Jun 20, 2019 after 301 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- 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 K051306 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971272: Trauma-Fix External Fixator, Trend Medical, Inc. (1997) Summary page 4.
- K111786: Hoffmann 3 Modular External Fixation System, Stryker Corp. (2012) Summary page 4.
- K121252: Hoffmann 3 Modular External Fixation System, Stryker Corp. (2012) Summary page 4.
- K122284: Hoffmann 3, Stryker Corp. (2012) Summary page 4.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 4.

## Indications for use
The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia: - Temporary fracture fixation - Correction of deformity - Osteotomy - Bone union - Bone reconstruction - Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality - Leg lengthening

Source page: https://510kreport.com/device/K182285
Methodology: https://510kreport.com/methodology