# K151508: IRENE Locking Compression Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Zhengtian Medical Instrument Co., Ltd.
- Decided: Feb 25, 2016 after 266 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: 7 generations back to K981372 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101400: Locking Compression Plate, Changzhou Orthmed Medical Instrument Co., Ltd. (2010) Summary page 5.
- K100721: Locking Bone Screw Model HCQ04, HCZ04, Changzhou Orthmar Medical Instrument Co., Ltd. (2010) Summary page 5.
- K112819: Reconstruction Locking Plate and 3.5MM Locking Screw, Xiamen Double Engline Medical Material Co., Ltd. (2011) Summary page 5.

## Indications for use
The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

Source page: https://510kreport.com/device/K151508
Methodology: https://510kreport.com/methodology