Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

HWE — Predicate Candidate Screening

76 FDA 510(k) clearances under this product code; the 50 most recent screened below.

76 daysmedian FDA review time

269 days90th percentile

76clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143191	IntelliSense Drill	Mcginley Innovations	2015-02-20	106	0
K102743	ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES	Ortho Solutions Limited	2011-01-20	120	0
K063688	SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE	The Anspach Effort, Inc.	2007-01-16	35	0
K050766	EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM	Zimmer Trabecular	2005-05-26	62	0
K043310	SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM	Synthes (Usa)	2005-01-05	35	6
K022744	REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS	Medical Device Services	2002-09-18	30	0
K012676	REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS	Adven Medical	2002-02-04	174	0
K012694	REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS	Adven Medical	2002-02-04	174	0
K990816	AVCORE SYSTEM	Modular Cutting Systems, Inc.	1999-09-24	197	0
K973736	AESCULAP HILAN MOTOR SYSTEM	Aesculap, Inc.	1997-12-29	89	0
K973560	BONE GRAFT HARVESTER	Ds Mfg., Inc.	1997-11-12	54	0
K972508	SURGICAL BURS AND SURGICAL DRILL BITS	Synvasive Technology, Inc.	1997-08-26	54	0
K971342	DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD	Disk Whisk, Inc.	1997-07-08	89	0
K971544	SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)	Synthes (Usa)	1997-05-28	30	0
K962087	SERVOTRONIC EC100 SYSTEM	Medicon, Inc.	1997-04-23	330	0
K970088	RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3	Richard Wolf Medical Instruments Corp.	1997-04-07	87	0
K970040	SPINE-TECH BONE HARVESTER	Spine-Tech, Inc.	1997-02-28	53	0
K970023	MEDNEXT SURGICAL BUR	Mednext, Inc.	1997-02-28	56	0
K962913	SYNTHES STERILE DRILL BITS	Synthes (Usa)	1996-11-14	111	0
K962800	STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES	Stryker Instruments	1996-09-11	55	0
K962215	CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUT	U.S. Medical Products, Inc.	1996-08-15	66	0
K962022	POWERCUT GOLD SURGICAL SYSTEM	Baxter Healthcare Corp	1996-08-05	74	0
K961970	COMMAND 2 MICOELECTRIC SURGICAL SYSTEM	Stryker Corp.	1996-07-26	67	2
K961759	CEMENT AND BONE REMOVAL KIT	Maillefer Instruments S.A.	1996-06-13	37	0
K960720	EXACTECH STERILE MODULAR DRILL BIT	Exactech, Inc.	1996-04-23	61	0
K960852	HALL MODULAR ACETABULAR REAMER SYSTEM	Linvatec Corp.	1996-03-20	19	0
K953968	AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)	Aesculap, Inc.	1996-02-05	167	0
K955098	3M MINI-DRIVER ELECTRIC SYSTEM	3M Company	1996-01-22	76	0
K955591	MICROAIRE SMARTDRIVE SYSTEM	Microaire Surgical Instruments, Inc.	1996-01-18	42	0
K952543	GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET	Neoligaments, Ltd.	1995-06-22	35	0
K950013	CONSENSUS(TM) ORTHOPEDIC DRILL BIT	U.S. Medical Products, Inc.	1995-05-05	122	0
K946197	CONSENSUS(TM) PATELLA REAMER	U.S. Medical Products, Inc.	1995-04-05	106	0
K944946	CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER	U.S. Medical Products, Inc.	1995-02-01	117	0
K945186	CONSENUS HIP SYSTEM -- ACETABULAR REAMER	U.S. Medical Products, Inc.	1995-01-27	95	0
K945189	CONSENSUS HIP SYSTEM -- CALCAR PLANER	U.S. Medical Products, Inc.	1995-01-27	95	0
K945208	CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER	U.S. Medical Products, Inc.	1995-01-27	94	0
K943589	STRYKER TOTAL PERFORMANCE SYSTEM	Stryker Corp.	1994-12-15	146	0
K942108	COHORT BONE BRUSH	Advanced Med/Surg, Inc.	1994-10-11	162	0
K942956	SURGICAL INSTRUMENTS AND ACCESSORIES	Stryker Corp.	1994-09-23	92	0
K942660	HALL MICROCHOICE ELECTRIC POWERED SYSTEM	Hall Surgical, Division of Zimmer, Inc.	1994-09-07	93	1
K932918	TOTAL KNEE KIT	Biodynamic Technologies, Inc.	1994-09-01	443	0
K931429	COOL CUT	Mitab	1994-04-29	403	0
K935753	THE GRAFTOLOGER	Neoligaments, Ltd.	1994-04-25	150	0
K931734	INTERMEDICS ORTHOPEDICS DRILL BITS	Intermedics Orthopedics	1994-02-22	321	0
K935322	SNAP BONE REAMER	Surgiquip, Inc.	1994-01-28	85	0
K935516	SNAP DRILL	Surgiquip, Inc.	1994-01-27	70	0
K931176	BONE SAW BLADES	Betzler Mfg., Inc.	1994-01-26	323	0
K932699	ARTHREX AR-8200 SHAVER SYSTEM	Arthrex, Inc.	1994-01-25	236	0
K935567	SODEM POWER SYSTEM	Sodemsystems	1994-01-21	64	0
K930319	OSTEON ADAPTOR/CRADLE	United American Medical Co., Inc.	1994-01-07	350	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda