# Ht Medical D.B.A. Xenix Medical

- Location (FDA's records): Orlando, FL
- FDA decisions: 4 (2023–2025): 4 510(k) clearances
- Names in FDA's records: Ht Medical D.B.A. Xenix Medical (3); Ht Medical, LLC Dba Xenix Medical (1)
- Product codes: OUR (2), NKB (1), ODP (1)
- 510(k) review time since 2016: median 57 days, against 58 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 5 (1 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
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Spinefrontier, Inc.: 1 (https://510kreport.com/company/spinefrontier)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Atlas Spine, Inc.: 1 (https://510kreport.com/company/atlas-spine)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Firms that cite its devices most
- Xenix Medical: 3 (https://510kreport.com/company/xenix-medical)
- Spectrum Spine, LLC: 1 (https://510kreport.com/company/spectrum-spine)

## Its most-cited devices
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (2023), cited by 2
- K231829: Xenix Medical Sacroiliac Fixation System (2023), cited by 1
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (2025), cited by 1
- K233241: SOLACE Sacroiliac Fixation System (2023), cited by 1

## Recent decisions
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments (Jun 12, 2025)
- K233241: SOLACE Sacroiliac Fixation System (Oct 27, 2023)
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (Sep 1, 2023)
- K231829: Xenix Medical Sacroiliac Fixation System (Aug 15, 2023)

Source page: https://510kreport.com/company/ht-medical-dba-xenix-medical