Reamer
An orthopedic reamer is a rotating cutting instrument used during joint replacement or fracture fixation surgery to enlarge or shape the medullary canal or acetabulum to accept an implant. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HTO falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTO
- Device Class
- FDA class 1
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Aug 10, 2011 | Substantially Equivalent | Synthes (USA) Products, LLC |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Mar 16, 2005 | Substantially Equivalent | Synthes (Usa) |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Dec 21, 2001 | Substantially Equivalent | Synthes (Usa) |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Jun 12, 2000 | Substantially Equivalent | Synthes (Usa) |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Dec 28, 1995 | Substantially Equivalent | Zimmer, Inc. |
| K903248 | COMBINATION REAMER | Jul 30, 1990 | Substantially Equivalent | Onyx Medical Corp. |
| K885100 | MCCONNELL REAMER GUIDE | Jan 13, 1989 | Substantially Equivalent | Mcconnell Orthopedic |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Mar 11, 1987 | Substantially Equivalent | Warsaw Orthopedic, Inc. |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Aug 18, 1986 | Substantially Equivalent | Instrumentation Industries, Inc. |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Oct 14, 1983 | Substantially Equivalent | Hirata Sangyo Co. USA, Inc. |
| K811081 | MEDULLARY CANAL SCRAPERS | Apr 29, 1981 | Substantially Equivalent | The Anspach Effort, Inc. |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Jun 27, 1979 | Substantially Equivalent | Depuy, Inc. |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | Feb 22, 1979 | Substantially Equivalent | 3M Company |
| K770203 | HAND REAMERS | Feb 08, 1977 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 354 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 354 registration numbers. Click on an entry to view related FDA registrations.