# K031595: U & I America Spinal Hook System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp., America
- Decided: Jun 24, 2003 after 34 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884263 (1988). 8 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983904: Rogozinski Spinal Rod System, United States Surgical, A Division of Tyco Healthc (1998). Our reading of the summary gave K983804, FDA’s number for The Aptus (Automated) Application of the Ebv-EA Igg Elisa… (Zeus Scientific, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “United States Surgical Corporation, Rogozinski Spinal System”.
- K001319: Xia Spine System Hooks, Howmedica Osteonics Corp. (2000) Summary page 1.
- K955807: Cotrel-Dubousset (CD) Spinal, Sofamor Danek USA,Inc. (1996) Summary page 1.

## Most influential descendants
- K113324: Rexious Hook Fixation Systems (2012), 6 descendants of its own
- K123476: Mega 5.5 Spine System (2013), 5 descendants of its own
- K171497: Mikron Spinal Fixation System (2017), 4 descendants of its own
- K241657: MSFX Mikron Spinal Fixation System (2024), 3 descendants of its own
- K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation (2013), 2 descendants of its own

## Recalls of this device
- Aug 10, 2004 · Not classified · Z-1438-04: Threads on a set screw, as a component of a spinal fixation system, may break off during use.
- Jan 14, 2004 · Not classified · Z-0559-04: Reports of hex driver tips breaking off or becoming worn or stripped.
- Jan 14, 2004 · Not classified · Z-0558-04: Reports of hex driver tips breaking off or becoming worn or stripped.

## Indications for use
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The U & I Spinal Hook and Rod System can be used in conjunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.

Source page: https://510kreport.com/device/K031595
Methodology: https://510kreport.com/methodology