# Paradigm Spine, LLC

- Location (FDA's records): Washington, DC
- FDA decisions: 16 (2008–2022): 16 510(k) clearances
- Names in FDA's records: Paradigm Spine, LLC (11); Paradigm Spine (3); Paradigm Spine GmbH (2)
- Product codes: NQP (5), NKB (3), PEK (2), KWP (2), ODP (1), MNH (1), MNI (1), MAX (1)
- 510(k) review time since 2016: median 128 days, against 106 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 51 (23 its own); citations of its devices by later devices: 30 (23 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.): 3 (https://510kreport.com/company/pioneer-surgical-technology-dba-rti-surgical)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek: 3 (https://510kreport.com/company/medtronic-sofamor-danek)
- Rti Surgical, Inc.: 2 (https://510kreport.com/company/rti-surgical)
- Lanx, Inc.: 2 (https://510kreport.com/company/lanx)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Acromed Corp.: 2 (https://510kreport.com/company/acromed)
- Eit Emerging Implant Technologies GmbH: 2 (https://510kreport.com/company/eit-emerging-implant-technologies)

## Firms that cite its devices most
- Precision Spine, Inc.: 2 (https://510kreport.com/company/precision-spine)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Flospine: 1 (https://510kreport.com/company/flospine)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Carlsmed, Inc.: 1 (https://510kreport.com/company/carlsmed)

## Its most-cited devices
- K080241: DDS Stabilization System (2008), cited by 5
- K090408: Modification to: DSS Stabilization System (2009), cited by 4
- K090099: DSS Stabilization System (2009), cited by 4
- K071668: Orthobiom Spinal System (2008), cited by 3
- K093438: Paradigm Interspinous Fusion Plate (2010), cited by 3
- K153302: coflex-IF (2016), cited by 2

## Recent decisions
- K213493: Fortilink with TiPlus Technology (Jan 27, 2022)
- K201453: Fortilink Cages with TiPlus Technology (Oct 7, 2020)
- K201704: CoFix System (Aug 4, 2020)
- K153302: coflex-IF (Sep 8, 2016)
- K120491: DSS Stabilization System-Rigid (May 9, 2012)
- K112595: Coflex-F (Feb 13, 2012)
- K113625: DSS Stabilization System (Jan 10, 2012)
- K093438: Paradigm Interspinous Fusion Plate (Oct 6, 2010)

Source page: https://510kreport.com/company/paradigm-spine