DePuy Synthes TFNA Augmentation System— 510(k) K160167
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K160167 for DePuy Synthes TFNA Augmentation System, Substantially Equivalent on 2016-09-26. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Synthes (USA) Products, LLC
view all- K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- K212943 — SyntheCel Dura Repair
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K210408 — DePuy Synthes Variable Angle Locking Patella Plating System
- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160167
K-number listed on FDA's recall record- Z-1239-2024 — TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
- Z-1240-2024 — TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160167.
Data sourced from openFDA. This site is unofficial and independent of the FDA.