# K063601: Pilot Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Jan 25, 2007 after 52 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: 2 generations back to K951725 (1995). 6 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 1.
- K052971: Stryker Spine Trio Spinal Fixation System, Stryker Spine (2005) Summary page 1.

## Most influential descendants
- K111729: Pilot Spinal System (2011), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own
- K082617: Trauson General Spinal System (GSS) (2009), 8 descendants of its own

## Indications for use
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The PILOTTM Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities. When used as a posterior spine thoracic/lumbar system, the PILOTrm Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Source page: https://510kreport.com/device/K063601
Methodology: https://510kreport.com/methodology