SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
FDA 510(k) clearance K111437 · decided 2011-08-10
Clearance details
- K-number
- K111437
- Device name
- SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-05-24
- Decision date
- 2011-08-10
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HTO
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899) | Synthes (Usa) | 2005-03-16 |
| MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (K013527) | Synthes (Usa) | 2001-12-21 |
| SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (K993335) | Synthes (Usa) | 2000-06-12 |
| FLEXIBLE INTRAMEDULLARY REAMER (K954915) | Zimmer, Inc. | 1995-12-28 |
| COMBINATION REAMER (K903248) | Onyx Medical Corp. | 1990-07-30 |
| MCCONNELL REAMER GUIDE (K885100) | Mcconnell Orthopedic | 1989-01-13 |
| WARSAW ORTHOPEDIC POINTED REAMER (K870845) | Warsaw Orthopedic, Inc. | 1987-03-11 |
| ABC-1000 SMALL JOINT REAMERS (K862933) | Instrumentation Industries, Inc. | 1986-08-18 |
| MULTIPLE MANUAL SURGICAL INSTRUMENTS (K832686) | Hirata Sangyo Co. USA, Inc. | 1983-10-14 |
| MEDULLARY CANAL SCRAPERS (K811081) | The Anspach Effort, Inc. | 1981-04-29 |
| C.C.F. FEMORAL DEBRIDEMENT PROBE (K790996) | Depuy, Inc. | 1979-06-27 |
| FLEXIBLE REAMER, GUIDE WIRE SYSTEM (K790307) | 3M Company | 1979-02-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolesce recall (Z-1237-2024) | Synthes (USA) Products LLC | 2024-03-01 |
| Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA recall (Z-2092-2015) | Synthes, Inc. | 2015-07-16 |