# Titan Spine, LLC

- Location (FDA's records): Mequon, WI
- FDA decisions: 19 (2008–2020): 19 510(k) clearances
- Names in FDA's records: Titan Spine, LLC (14); Titan Spine, Inc. (5)
- Product codes: MAX (7), ODP (4), OVD (4), OVE (4)
- 510(k) review time since 2016: median 72 days, against 92 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 96 (52 its own); citations of its devices by later devices: 78 (52 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orthovita, Inc.: 4 (https://510kreport.com/company/orthovita)
- Surgicraft, Ltd.: 4 (https://510kreport.com/company/surgicraft)
- Zimmer Spine, Inc.: 4 (https://510kreport.com/company/zimmer-spine)
- Stryker Spine: 4 (https://510kreport.com/company/stryker-spine)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Sofamor Danek: 2 (https://510kreport.com/company/sofamor-danek)

## Firms that cite its devices most
- Astura Medical: 3 (https://510kreport.com/company/astura-medical)
- Life Spine, Inc.: 2 (https://510kreport.com/company/life-spine)
- Curiteva, Inc.: 2 (https://510kreport.com/company/curiteva)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)
- Expanding Innovations, Inc.: 1 (https://510kreport.com/company/expanding-innovations)

## Its most-cited devices
- K100889: Endoskeleton TC (2010), cited by 12
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL (2014), cited by 8
- K080615: Endoskeleton TA Interbody Fusion Device (Ibd) (2008), cited by 7
- K102067: Endoskeleton to (2010), cited by 6
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd) (2009), cited by 6
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), cited by 5

## Recent decisions
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (Jan 8, 2020)
- K192054: Endoskeleton TAS Plate (Aug 29, 2019)
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (Aug 16, 2019)
- K191565: Endoskeleton TCS Interbody Fusion Device (Aug 6, 2019)
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (Feb 11, 2019)
- K173535: Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device (Feb 13, 2018)
- K170399: Endoskeleton TO Interbody Fusion Device (IBD) (Jul 6, 2017)
- K163269: Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device (Apr 13, 2017)

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