# K110046: Athena Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Royal Oak Medical Devices
- Decided: Dec 7, 2011 after 335 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 4 generations back to K901587 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 2.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 2.
- K930298: Rogozinski Spinal Rod System Screw, Smith & Nephew Richards, Inc. (1995) Summary page 2.
- K983904: Rogozinski Spinal Rod System, United States Surgical, A Division of Tyco Healthc (1998). Our reading of the summary gave K953904, FDA’s number for Sarns 9000 Universal Roller Pump (3M Health Care, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rogozinski System”.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 2.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 2.

## Indications for use
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (ODD) (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 (ie., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrcsis; and failed previous fusion.

Source page: https://510kreport.com/device/K110046
Methodology: https://510kreport.com/methodology