# K120291: OP Spine System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 16, 2012 after 76 days
- Product code: OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis)
- 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: 5 generations back to K990745 (1999). 50 ancestors in all.
138 later devices descend from it; 4 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 1.
- K081952: Synergy Spinal System (6.35 Polaris), Biomet Spine (2008) Summary page 1.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 1.
- K022285: Modification to Isola Spinal System, Depuyacromed (2002) Summary page 1.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 1.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 1.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001) Summary page 1.
- K982511: Depuy Motech Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 1.

## Most influential descendants
- K121630: Range Spinal System (2012), 127 descendants of its own
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own
- K151488: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (2015), 78 descendants of its own
- K153428: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (2016), 73 descendants of its own
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (2017), 61 descendants of its own

## Indications for use
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K120291
Methodology: https://510kreport.com/methodology