HTO · Reamer
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HTO |
|---|---|
| Device Name | Reamer |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | Aug 10, 2011 | SESE |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | Mar 16, 2005 | SESE |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | Dec 21, 2001 | SESE |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | Jun 12, 2000 | SESE |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | Dec 28, 1995 | SESE |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | Jul 30, 1990 | SESE |
| K885100 | MCCONNELL REAMER GUIDE | Mcconnell Orthopedic | Jan 13, 1989 | SESE |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Warsaw Orthopedic, Inc. | Mar 11, 1987 | SESE |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | Aug 18, 1986 | SESE |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Hirata Sangyo Co. USA, Inc. | Oct 14, 1983 | SESE |
| K811081 | MEDULLARY CANAL SCRAPERS | The Anspach Effort, Inc. | Apr 29, 1981 | SESE |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Depuy, Inc. | Jun 27, 1979 | SESE |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | 3M Company | Feb 22, 1979 | SESE |
| K770203 | HAND REAMERS | Depuy, Inc. | Feb 8, 1977 | SESE |
Top Applicants
- Synthes (Usa) — 3 clearances
- Depuy, Inc. — 2 clearances
- Zimmer, Inc. — 1 clearance
- Warsaw Orthopedic, Inc. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
