# K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments

- Pathway: 510(k) (Special)
- Applicant: Iame, Inc.
- Decided: Sep 10, 2002 after 117 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901587 (1990). 16 ancestors in all.
175 later devices descend from it; 7 cite it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993503: Haider-Ucr Spinal System, International Advanced Medical Enterprises, Inc. (2000) Summary page 3.

## Most influential descendants
- K032739: Ucr Spinal System (2003), 174 descendants of its own
- K043232: Ucr Spinal System (2004), 97 descendants of its own
- K081331: Fixxsure Cross Link (2008), 91 descendants of its own
- K110692: Streamline TL Spinal System (2011), 89 descendants of its own
- K111502: Streamline TL Spinal System (2011), 88 descendants of its own

## Indications for use
The HAIDER-UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous hsion pseudarthrosis)

Source page: https://510kreport.com/device/K021623
Methodology: https://510kreport.com/methodology