Product Code: HWE
FDA class 1
21 CFR 878.4820
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
General, Plastic Surgery
An AC-powered motor surgical instrument and accessory/attachment is an electrically powered orthopedic surgical tool used for drilling, sawing, reaming, or driving implants during surgical procedures, along with associated accessories. It is classified as an FDA Class 1 device under 21 CFR 878.4820, indicating low risk and general controls only. Product code HWE falls under the General and Plastic Surgery medical specialty.
510(k)s
76
FEI Numbers
387
Registration Numbers
387
Unique Applicants
54
Years Active
38
Basic Information
- Product Code
- HWE
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 76 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143191 | IntelliSense Drill | Feb 20, 2015 | Substantially Equivalent | Mcginley Innovations |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | Jan 20, 2011 | Substantially Equivalent | Ortho Solutions Limited |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | Jan 16, 2007 | Substantially Equivalent | The Anspach Effort, Inc. |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | May 26, 2005 | Substantially Equivalent | Zimmer Trabecular |
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | Jan 05, 2005 | Substantially Equivalent | Synthes (Usa) |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Sep 18, 2002 | Substantially Equivalent | Medical Device Services |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Feb 04, 2002 | Substantially Equivalent | Adven Medical |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Feb 04, 2002 | Substantially Equivalent | Adven Medical |
| K990816 | AVCORE SYSTEM | Sep 24, 1999 | Substantially Equivalent | Modular Cutting Systems, Inc. |
| K973736 | AESCULAP HILAN MOTOR SYSTEM | Dec 29, 1997 | Substantially Equivalent | Aesculap, Inc. |
| K973560 | BONE GRAFT HARVESTER | Nov 12, 1997 | Substantially Equivalent | Ds Mfg., Inc. |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Aug 26, 1997 | Substantially Equivalent | Synvasive Technology, Inc. |
| K971342 | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | Jul 08, 1997 | Substantially Equivalent | Disk Whisk, Inc. |
| K971544 | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | May 28, 1997 | Substantially Equivalent | Synthes (Usa) |
| K962087 | SERVOTRONIC EC100 SYSTEM | Apr 23, 1997 | Substantially Equivalent | Medicon, Inc. |
| K970088 | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | Apr 07, 1997 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K970040 | SPINE-TECH BONE HARVESTER | Feb 28, 1997 | Substantially Equivalent | Spine-Tech, Inc. |
| K970023 | MEDNEXT SURGICAL BUR | Feb 28, 1997 | Substantially Equivalent | Mednext, Inc. |
| K962913 | SYNTHES STERILE DRILL BITS | Nov 14, 1996 | Substantially Equivalent | Synthes (Usa) |
| K962800 | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | Sep 11, 1996 | Substantially Equivalent | Stryker Instruments |
| K962215 | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | Aug 15, 1996 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K962022 | POWERCUT GOLD SURGICAL SYSTEM | Aug 05, 1996 | Substantially Equivalent | Baxter Healthcare Corp |
| K961970 | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM | Jul 26, 1996 | Substantially Equivalent | Stryker Corp. |
| K961759 | CEMENT AND BONE REMOVAL KIT | Jun 13, 1996 | Substantially Equivalent | Maillefer Instruments S.A. |
| K960720 | EXACTECH STERILE MODULAR DRILL BIT | Apr 23, 1996 | Substantially Equivalent | Exactech, Inc. |
| K960852 | HALL MODULAR ACETABULAR REAMER SYSTEM | Mar 20, 1996 | Substantially Equivalent | Linvatec Corp. |
| K953968 | AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) | Feb 05, 1996 | Substantially Equivalent | Aesculap, Inc. |
| K955098 | 3M MINI-DRIVER ELECTRIC SYSTEM | Jan 22, 1996 | Substantially Equivalent | 3M Company |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | Jan 18, 1996 | Substantially Equivalent | Microaire Surgical Instruments, Inc. |
| K952543 | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET | Jun 22, 1995 | Substantially Equivalent | Neoligaments, Ltd. |
| K950013 | CONSENSUS(TM) ORTHOPEDIC DRILL BIT | May 05, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K946197 | CONSENSUS(TM) PATELLA REAMER | Apr 05, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K944946 | CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER | Feb 01, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K945208 | CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER | Jan 27, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K945189 | CONSENSUS HIP SYSTEM -- CALCAR PLANER | Jan 27, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K945186 | CONSENUS HIP SYSTEM -- ACETABULAR REAMER | Jan 27, 1995 | Substantially Equivalent | U.S. Medical Products, Inc. |
| K943589 | STRYKER TOTAL PERFORMANCE SYSTEM | Dec 15, 1994 | Substantially Equivalent | Stryker Corp. |
| K942108 | COHORT BONE BRUSH | Oct 11, 1994 | Substantially Equivalent | Advanced Med/Surg, Inc. |
| K942956 | SURGICAL INSTRUMENTS AND ACCESSORIES | Sep 23, 1994 | Substantially Equivalent | Stryker Corp. |
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM | Sep 07, 1994 | Substantially Equivalent | Hall Surgical, Division of Zimmer, Inc. |
| K932918 | TOTAL KNEE KIT | Sep 01, 1994 | Substantially Equivalent | Biodynamic Technologies, Inc. |
| K931429 | COOL CUT | Apr 29, 1994 | Substantially Equivalent | Mitab |
| K935753 | THE GRAFTOLOGER | Apr 25, 1994 | Substantially Equivalent | Neoligaments, Ltd. |
| K931734 | INTERMEDICS ORTHOPEDICS DRILL BITS | Feb 22, 1994 | Substantially Equivalent | Intermedics Orthopedics |
| K935322 | SNAP BONE REAMER | Jan 28, 1994 | Substantially Equivalent | Surgiquip, Inc. |
| K935516 | SNAP DRILL | Jan 27, 1994 | Substantially Equivalent | Surgiquip, Inc. |
| K931176 | BONE SAW BLADES | Jan 26, 1994 | Substantially Equivalent | Betzler Mfg., Inc. |
| K932699 | ARTHREX AR-8200 SHAVER SYSTEM | Jan 25, 1994 | Substantially Equivalent | Arthrex, Inc. |
| K935567 | SODEM POWER SYSTEM | Jan 21, 1994 | Substantially Equivalent | Sodemsystems |
| K932261 | ES-100 ACCESSORIES | Jan 07, 1994 | Substantially Equivalent | Elekta Instruments, Inc. |
| K931837 | ACUFEX STERILE DRILLS | Jan 07, 1994 | Substantially Equivalent | Acufex Microsurgical, Inc. |
| K930363 | POWERED SURGICAL INSTRUMENT ACCESSORY | Jan 07, 1994 | Substantially Equivalent | Intenn Engineering, Inc. |
| K930319 | OSTEON ADAPTOR/CRADLE | Jan 07, 1994 | Substantially Equivalent | United American Medical Co., Inc. |
| K922056 | HHI ELECTRIC CONSOLE #875-000 | Sep 18, 1992 | Substantially Equivalent | H&H Instruments |
| K921131 | CKS OSCILLATING SAW BLADE | Jun 08, 1992 | Substantially Equivalent | Techmedica, Inc. |
| K911930 | STERILE PACKAGED POWER INSTRUMENT ACCESSORIES | Jul 02, 1991 | Substantially Equivalent | United American Medical Co., Inc. |
| K911929 | SMALL BONE FIXATION SYSTEM | Jul 02, 1991 | Substantially Equivalent | United American Medical Co., Inc. |
| K902525 | ACE/WILLIAMS MICROSURGERY SAW SYSTEM | Nov 26, 1990 | Substantially Equivalent | Buckman Co., Inc. |
| K903650 | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 | Sep 14, 1990 | Substantially Equivalent | Micro-Aire Surgical Instruments, Inc. |
| K902447 | CORING NEEDLE (TREPHINE, ORTHOPEDIC) | Aug 14, 1990 | Substantially Equivalent | Biomedtrix, Ltd. |
| K902332 | HALL MODULAR ACETABULAR REAMER SYSTEM | Jun 25, 1990 | Substantially Equivalent | Zimmer, Inc. |
| K901165 | MODULAR FLEXIBLE DRILLING SYSTEM | Jun 13, 1990 | Substantially Equivalent | Dalton Technology, Inc. |
| K895198 | HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM | Sep 15, 1989 | Substantially Equivalent | Zimmer, Inc. |
| K882008 | ACE SCREW REMOVAL TREPHINE | Jun 10, 1988 | Substantially Equivalent | Buckman Co., Inc. |
| K880150 | PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM | Mar 04, 1988 | Substantially Equivalent | Dyonics, Inc. |
| K874044 | INTRA-ARTICULAR ARTHROSCOPIC SHAVER | Oct 15, 1987 | Substantially Equivalent | Medline Industries, Inc. |
| K871717 | MODEL 28200C MICRO-ARTHROPLASTY SYSTEM | Jun 05, 1987 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K864929 | HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST | Jan 28, 1987 | Substantially Equivalent | Hall Surgical, Division of Zimmer, Inc. |
| K855216 | 3M ARTHROSCOPIC SURGICAL SYSTEM | Mar 04, 1986 | Substantially Equivalent | 3M Company |
| K854987 | INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM | Feb 11, 1986 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K853376 | MORGAN SUTURE-DRILL | Nov 13, 1985 | Substantially Equivalent | Bowen & Company, Inc. |
| K853489 | DEXTRA PRECISION POWER SYSTEM | Sep 30, 1985 | Substantially Equivalent | Chattanooga Group, Inc. |
| K833940 | TORQUE PLUS CATALOG 30120 | Dec 28, 1983 | Substantially Equivalent | Concept, Inc. |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent | Cutter Laboratories, Inc. |
| K792353 | INTRA-ARTICULATED EDGER-PLANER SYSTEM | Dec 27, 1979 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K760977 | CHARNLEY FEMUR DRILL #1 AND #2 | Nov 16, 1976 | Substantially Equivalent | Codman & Shurtleff, Inc. |
FEI Numbers
This FDA classification entry is associated with 387 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 387 registration numbers. Click on an entry to view related FDA registrations.