# K081588: RE-Zorb Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Acute Innovations, LLC
- Decided: Sep 3, 2008 after 90 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: 4 generations back to K974017 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063410: Inion CPS/Otps Freedomplate, Inion, Ltd. (2007) Summary page 1.

## Most influential descendants
- K120163: Acute Innovations Biobridge Resorbable Plating System (2012), 0 descendants of its own

## Indications for use
In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications: 1. Craniofacial skeleton, cranium, mid-face, maxilla, and mandible 2. Metacarpus, proximal and middle phalangeal bones 3. Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Source page: https://510kreport.com/device/K081588
Methodology: https://510kreport.com/methodology