OIC External Fixation System
FDA 510(k) K211112 · Orthopaedic Implant Company
510(k) numberK211112
Submission
- Device name
- OIC External Fixation System
- Applicant
- Orthopaedic Implant Company
Reno, NV, US - Received
- April 14, 2021
- Decision date
- May 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate SystemHRS · Special | 10/23/2024SE |
| K233531 | OIC FLEX-FIX SystemHTN · Traditional | 02/02/2024SE |
| K223761 | OIC Intramedullary Screw SystemHWC · Traditional | 02/13/2023SE |
| K223118 | OIC Variable Angle Small Fragment Locking Plate SystemHRS · Traditional | 01/21/2023SE |
| K212601 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 04/05/2022SE |
| K202971 | DRPx Locking Distal Radius Plate SystemHRS · Traditional | 05/06/2021SE |
| K183682 | OIC External Fixation SystemKTT · Traditional | 04/08/2019SE |
| K182736 | OIC Suture Anchor SystemMBI · Traditional | 12/28/2018SE |
| K181184 | OIC Intramedullary Nail SystemHSB · Special | 07/27/2018SE |
| K171211 | OIC External Fixation SystemKTT · Traditional | 09/27/2017SE |
Questions and answers
When was OIC External Fixation System cleared by the FDA?
OIC External Fixation System (K211112) received a 510(k) decision of Substantially Equivalent on May 5, 2021, 21 days after the submission was received.
What is the product code of K211112?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.