Product code HTO
- Device name
- Reamer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | 2011-08-10 |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | 2005-03-16 |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2001-12-21 |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2000-06-12 |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | 1995-12-28 |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | 1990-07-30 |
| K885100 | MCCONNELL REAMER GUIDE | Mcconnell Orthopedic | 1989-01-13 |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Warsaw Orthopedic, Inc. | 1987-03-11 |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | 1986-08-18 |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Hirata Sangyo Co. USA, Inc. | 1983-10-14 |
| K811081 | MEDULLARY CANAL SCRAPERS | The Anspach Effort, Inc. | 1981-04-29 |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Depuy, Inc. | 1979-06-27 |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | 3M Company | 1979-02-22 |
| K770203 | HAND REAMERS | Depuy, Inc. | 1977-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810094692797 | Tibial Reamer, Square Tip, Klassic ONE 25/50mm | TOTAL JOINT ORTHOPEDICS, INC. | 2026-06-09 |
| 00810030810698 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810681 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810674 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810667 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810650 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810643 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810636 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810629 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810612 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810605 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810599 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810582 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810575 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810704 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030810414 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810421 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810438 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810445 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810452 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810469 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-31 |
| 00810030810377 | iNSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-30 |
| 00810030810391 | iNSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-05-30 |
| 10855068008256 | Cannulated Flexible Reamer, 6.0mm | CURVAFIX, INC. | 2022-12-05 |
| 10855068008317 | 9.0MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |
| 10855068008300 | 8.5MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |
| 10855068008294 | 8.0MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |
| 10855068008287 | 7.5MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |
| 10855068008270 | 7.0MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |
| 10855068008263 | 6.5MM Flexible Reamer | CURVAFIX, INC. | 2021-08-11 |