# K161225: Paonan Armstrong Posterior Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Paonan Biotech Co., Ltd.
- Decided: Aug 11, 2017 after 452 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: 15 generations back to K990745 (1999). 170 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051704: Mykres Spinal System, Showa Ika Kohgyo Co., Ltd. (2006) Summary page 4.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 4.
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System, Cross Medical Products, Inc. (1998) Summary page 4.
- K993808: Synergy Integral Screws, Model Numbers 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220, Interpore Cross Intl. (1999) Summary page 4.
- K142146: Ibis Pedicle Screw System, Ortho Development Corp. (2014) Summary page 4.
- K162995: Ibis® Pedicle Screw System, Ortho Development Corporation (2017). Cleared while this submission was under review Summary page 4.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 4.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 4.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 4.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 4.

## Most influential descendants
- K180226: TREND II Spinal Fixation System- STEP Series (2018), 1 descendant of its own
- K240233: Pitkar Spinal Pedicle Screw System (2024), 0 descendants of its own

## Indications for use
“Paonan” Armstrong Posterior Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) for the following indications: – Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) degeneration of the disc confirmed by history and radiographic studies) – Degenerative Spondylolisthesis with objective evidence of neurologic impairment. – Fractures – Dislocation – Scoliosis – Kyphosis – Spinal tumor – Failed previous fusion (pseudarthrosis)

Source page: https://510kreport.com/device/K161225
Methodology: https://510kreport.com/methodology