DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S
K160553 is the FDA 510(k) clearance record for DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S, a class II device, cleared for Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 5 510(k) clearances for Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K160553.
Clearance record
- Decision date
- Received
- (487 days to decision)
- Product code
- HRS Plate, Fixation, Bone
- Regulation
- 21 CFR 888.3030
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. 1301 Goshen Pkwy., West Chester PA
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code HRS
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 5 |
| December 2025 | 5 |
| January 2026 | 4 |
| February 2026 | 5 |
| March 2026 | 13 |
| April 2026 | 6 |
| May 2026 | 2 |
| June 2026 | 5 |
| July 2026 | 5 |
| August 2026 | 3 |
| September 2026 | 4 |
| October 2026 | 0 |
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