# K041625: LTD Polyaxial Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Us Spinal Technologies, LLC
- Decided: Sep 8, 2004 after 85 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Moss Miami system: named in the summary without a submission number
- (no number) Xia Spine System: named in the summary without a submission number
- (no number) Optima Spine System: named in the summary without a submission number

## Most influential descendants
- K081296: Preference Pedicle Screw System (2008), 3 descendants of its own
- K081883: Modification to Preference Pedicle Screw System (2008), 2 descendants of its own
- K162160: Preference Elite Pedicle Screw System (2016), 1 descendant of its own
- K212185: Golden Isles Pedicle Screw System (2021), 0 descendants of its own

## Indications for use
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Source page: https://510kreport.com/device/K041625
Methodology: https://510kreport.com/methodology