# K070295: Single Planar Multi Axial (Spma) Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Orthopedics, LLC
- Decided: May 21, 2007 after 110 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 6 generations back to K950697 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 3.
- K982511: Depuy Motech Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 3.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 3.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 3.
- K001272: Xia Spine System, Howmedica Osteonics Corp. (2000)
- K043473: Modification to Xia Spinal System, Stryker Spine (2005) Summary page 3.
- K060979: Xia Titanium and 4.5 Spinal Systems, Stryker Spine (2006) Summary page 3.
- K063428: Xia Stainless Steel Spinal System, Stryker Spine (2006) Summary page 3.
- K961633: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1996) Summary page 3.
- K001255: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2000) Summary page 3.

## Cited in the summary but kept off the family tree
- K001971: Hemodialysis Tubing Sets, Ofi Biomedica S.P.A. (2001). Our reading of the summary gave K001971, FDA’s number for Hemodialysis Tubing Sets (Ofi Biomedica S.P.A.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OPTIMA Spinal System”. Kept off the family tree.

## Indications for use
The Single Planar Multi Axial (SPMA) Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K070295
Methodology: https://510kreport.com/methodology