# Osseus Fusion Systems, LLC

- Location (FDA's records): Dallas, TX
- FDA decisions: 10 (2013–2023): 10 510(k) clearances
- Names in FDA's records: Osseus Fusion Systems, LLC (5); Osseus Fusion Systems (5)
- Product codes: OVD (2), ODP (1), OUR (1), NKG (1), MNH (1), MAX (1), NKB (1), OLO (1), KWQ (1)
- 510(k) review time since 2016: median 104 days, against 108 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 64 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 7 (https://510kreport.com/company/depuy-spine)
- K2m, Inc.: 7 (https://510kreport.com/company/k2m)
- Vertebron, Inc.: 5 (https://510kreport.com/company/vertebron)
- Zimmer Spine, Inc.: 4 (https://510kreport.com/company/zimmer-spine)
- Nexxt Spine, LLC: 4 (https://510kreport.com/company/nexxt-spine)
- Synthes Spine: 3 (https://510kreport.com/company/synthes-spine)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Cross Medical Products, Inc.: 2 (https://510kreport.com/company/cross-medical-products)

## Firms that cite its devices most
- Degen Medical: 2 (https://510kreport.com/company/degen-medical)
- Mcnicoll Surgical, Inc.: 1 (https://510kreport.com/company/mcnicoll-surgical)
- BAAT Medical Products B.V.: 1 (https://510kreport.com/company/baat-medical-products)
- Genesys Spine: 1 (https://510kreport.com/company/genesys-spine)
- Pro Surgical, Inc.: 1 (https://510kreport.com/company/pro-surgical)
- Curiteva, Inc.: 1 (https://510kreport.com/company/curiteva)

## Its most-cited devices
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), cited by 4
- K181347: Aries® Lumbar Interbodies (2018), cited by 3
- K213590: Blue Topaz Sacroiliac Screw System (2022), cited by 1
- K223413: Pisces™-SA STANDALONE ALIF Interbody System (2023), cited by 1
- K131810: Osseus Black Diamond Pedicle Screw System (2013), cited by 1
- K192121: Black Diamond Pedicle Screw System (2019), cited by 1

## Recent decisions
- K223413: Pisces™-SA STANDALONE ALIF Interbody System (Feb 10, 2023)
- K222107: Black Diamond™ POCT Spinal System (Nov 3, 2022)
- K213935: PISCES-SA Standalone ALIF Interbody System (May 6, 2022)
- K213590: Blue Topaz Sacroiliac Screw System (Mar 1, 2022)
- K192495: Black Diamond Navigation Instruments (Jan 17, 2020)
- K192121: Black Diamond Pedicle Screw System (Oct 29, 2019)
- K181347: Aries® Lumbar Interbodies (Aug 15, 2018)
- K170844: Gemini-C Hybrid Cervical Interbody System (Jul 3, 2017)

Source page: https://510kreport.com/company/osseus-fusion-systems