UNITY Sacroiliac Joint Fixation System
FDA 510(k) K222448 · Dio Medical Corporation
510(k) numberK222448
Submission
- Device name
- UNITY Sacroiliac Joint Fixation System
- Applicant
- Dio Medical Corporation
East Norriton, PA, US - Received
- August 15, 2022
- Decision date
- October 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
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|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
More from Sivantage
| 510(k) | Device | Decision |
|---|---|---|
| K223790 | Huvex Interspinous Fusion SystemPEK · Traditional | 03/09/2023SE |
| K223140 | AEON-C Stand Alone SystemOVE · Traditional | 12/20/2022SE |
| K222415 | Rexious Spinal Fixation SystemNKB · Traditional | 10/25/2022SE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…KWQ · Traditional | 10/18/2022SE |
| K222515 | FaSet Fixation SystemMRW · Traditional | 10/05/2022SE |
| K162849 | Huvex Interspinous Fixation SystemPEK · Traditional | 02/16/2017SE |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageODP · Traditional | 11/21/2016SE |
| K122872 | Intervertebral Body Fusion DeviceODP · Traditional | 02/28/2013SE |
| K121862 | Rex Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2012SE |
| K113324 | Rexious Hook Fixation SystemsKWP · Traditional | 03/28/2012SE |
Questions and answers
When was UNITY Sacroiliac Joint Fixation System cleared by the FDA?
UNITY Sacroiliac Joint Fixation System (K222448) received a 510(k) decision of Substantially Equivalent on October 13, 2022, 59 days after the submission was received.
What is the product code of K222448?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.