Definition: Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation.
| Device Type ID | 5789 |
| Device Name | Suture, Recombinant Technology |
| Physical State | Polymer (solid) |
| Technical Method | Produced Through Recombinant DNA Technology |
| Target Area | General Soft Tissues In The Body. |
| Regulation Description | Absorbable Poly(hydroxybutyrate) Surgical Suture Produced By Recombinant DNA Technology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4494 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NWJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5789 |
| Device | Suture, Recombinant Technology |
| Product Code | NWJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Absorbable Poly(hydroxybutyrate) Surgical Suture Produced By Recombinant DNA Technology. |
| CFR Regulation Number | 878.4494 [🔎] |
| Device Problems | |
|---|---|
Break | 12 |
Packaging Problem | 10 |
Difficult To Open Or Remove Packaging Material | 7 |
Device Packaging Compromised | 4 |
Material Fragmentation | 2 |
Battery Charger, Defective | 2 |
Insufficient Information | 2 |
Detachment Of Device Or Device Component | 2 |
Product Quality Problem | 2 |
Fracture | 2 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Failure To Unwrap | 2 |
Appropriate Term/Code Not Available | 2 |
Degraded | 1 |
Material Frayed | 1 |
Human-Device Interface Problem | 1 |
Failure To Adhere Or Bond | 1 |
Device Damaged Prior To Use | 1 |
Detachment Of Device Component | 1 |
Sticking | 1 |
| Total Device Problems | 60 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tornier, Inc | II | Apr-13-2018 |