DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
K161616 is the FDA 510(k) clearance record for DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, a class II device, cleared for Synthes USA Products, LLC on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 479 510(k) clearances for Synthes USA Products, LLC, from to . As of , FDA records show no recalls naming K161616.
Clearance record
- Decision date
- Received
- (248 days to decision)
- Product code
- HWC Screw, Fixation, Bone
- Regulation
- 21 CFR 888.3040
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Synthes USA Products, LLC 1301 Goshen Pkwy., West Chester PA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code HWC
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 2 |
| April 2026 | 3 |
| May 2026 | 4 |
| June 2026 | 2 |
| July 2026 | 1 |
| August 2026 | 3 |
| September 2026 | 4 |
| October 2026 | 0 |
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