# Medtronic Sofamor Danek

- Location (FDA's records): Memphis, TN
- FDA decisions: 255 (2000–2025): 253 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Medtronic Sofamor Danek (154); Medtronic Sofamor Danek, Inc. (101)
- Product codes: NKB (50), KWP (44), MQP (30), MNI (23), KWQ (20), MAX (18), MNH (17), MQV (11), JDK (5), OVD (3), HRX (3), NUN (3)
- 510(k) review time since 2016: median 66 days, against 106 for FDA's reviews in the same codes and years (9 of 11 faster)
- Predicates its devices cite: 519 (285 its own); citations of its devices by later devices: 1,058 (285 its own)
- Recalls linked to its devices: 64 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 108 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Sofamor Danek USA,Inc.: 20 (https://510kreport.com/company/sofamor-danek-usa)
- Osteotech, Inc.: 9 (https://510kreport.com/company/osteotech)
- Depuy Spine, Inc.: 6 (https://510kreport.com/company/depuy-spine)
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- Biomatlante: 4 (https://510kreport.com/company/biomatlante)
- SI-BONE, Inc.: 4 (https://510kreport.com/company/si-bone)
- Ebi, L.P.: 3 (https://510kreport.com/company/ebi)

## Firms that cite its devices most
- Medtronic Sofamor Danek USA, Inc.: 272 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Reliance Medical Systems, LLC: 30 (https://510kreport.com/company/reliance-medical-systems)
- K2m, Inc.: 28 (https://510kreport.com/company/k2m)
- Globus Medical, Inc.: 17 (https://510kreport.com/company/globus-medical)
- Stryker Spine: 17 (https://510kreport.com/company/stryker-spine)
- Seaspine, Inc.: 13 (https://510kreport.com/company/seaspine)
- Medacta International S.A.: 12 (https://510kreport.com/company/medacta-international)
- Corelink, LLC: 10 (https://510kreport.com/company/corelink)

## Its most-cited devices
- K042025: Modification to CD Horizon Spinal System (2004), cited by 37
- K091445: CD Horizon Spinal System (2010), cited by 27
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems (2016), cited by 27
- K003780: Vertex Reconstruction System (2001), cited by 21
- K094025: Crescent Spinal System (2010), cited by 20
- K100175: Clydesdale Spinal System (2010), cited by 16

## Recent decisions
- K251193: Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (Jun 12, 2025)
- K243706: Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (Jan 17, 2025)
- K230716: Robotic Graft Delivery Instruments (Jul 18, 2023)
- K212428: Centerpiece Plate Fixation System (Dec 13, 2021)
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (Aug 26, 2020)
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System (Dec 20, 2017)
- K172199: ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium (Sep 19, 2017)
- K171031: CRESCENT™ Spinal System (Jul 6, 2017)

Source page: https://510kreport.com/company/medtronic-sofamor-danek