Definition: Is A Device Intended To Be Implanted That Consists Of A Polymeric Balloon That Is Inserted Into The Medullary (bone Marrow) Canal Of Long Bones For The Fixation Of Fractures. The Balloon Is Infused With A Liquid Monomer That Causes The Balloon To Fil
| Device Type ID | 4692 |
| Device Name | Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated |
| Physical State | Device Includes A Balloon Component To Contain The Light Sensitive Liquid Monomer. A Light Source (e.g., Optic Fiber) Is Used To Polymerize And Solidify The Monomer Into A Hardened Rigid Structure. Once Sufficiently Cured, The Device Possesses Adequa |
| Technical Method | A Polymeric Balloon Is Inserted Into The Intramedullary Canal Of Long Bones For The Fixation Of Fractures. The Balloon Is Infused With A Liquid Monomer That Causes The Balloon To Fill The Medullary Canal Of The Fractured Bone. The Device Is Then Expo |
| Target Area | Device Is Intended To Be Used In Long Bones Of The Body. |
| Regulation Description | In Vivo Cured Intramedullary Fixation Rod. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3023 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4692 |
| Device | Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated |
| Product Code | QAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | In Vivo Cured Intramedullary Fixation Rod. |
| CFR Regulation Number | 888.3023 [🔎] |
| Device Problems | |
|---|---|
Device Damaged By Another Device | 2 |
Off-Label Use | 1 |
Loss Of Osseointegration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Fracture | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 7 |