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

LXH — Predicate Candidate Screening

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

58 daysmedian FDA review time

210 days90th percentile

58clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192873	SX-One MicroKnife	Sonex Health, Inc.	2019-12-20	73	0
K140414	IMBIBE NEEDLE	Orthovita, Inc.	2014-04-01	42	1
K101609	SELF RETAINING SOFT TISSUE RETRACTOR	Koros USA, Inc.	2010-12-09	184	0
K001507	MICROPERFORATION INSTRUMENT	Smith & Nephew, Inc.	2000-06-14	30	0
K952495	ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM	Orthopedic Systems, Inc.	1996-01-22	237	0
K943873	ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY	Orthomet, Inc.	1995-04-26	260	0
K944188	SPINAL MARKER	Leibinger L.P.	1995-04-13	230	0
K941896	STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR	Depuy, Inc.	1994-11-07	203	0
K941711	HYPERFLEX FLEXIBLE GUIDEWIRES	Linvatec Corp.	1994-08-26	142	0
K941605	STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH	Stryker Corp.	1994-08-05	126	0
K933772	PUNCH SURGICAL	Mahe-Medizintechnik	1994-02-01	187	0
K933242	SOFAMOR ORTHOPAEDIC INSTRUMENTS	Danek Medical, Inc.	1994-01-28	210	0
K934260	BARRIER BONE WAX APPLICATOR	Phillips Pharmaceuticals, Inc.	1994-01-26	148	0
K931846	BIO-PREP	Biomedical Devices, Inc.	1994-01-21	283	0
K930028	CALMPS: BONE, MASTIN, LEWIN, BRAND	Thomasville Medical Assoc.	1993-02-16	42	0
K921402	SURGICAL INSTRUMENT, DISPOSABLE	Macro Medical, Inc.	1992-06-04	72	0
K921643	AMSEN POSTERIOR DISC EVACUATOR	Advanced Med/Surg, Inc.	1992-06-03	58	0
K921644	AMSEN HOCKEY STICK CHISEL	Advanced Med/Surg, Inc.	1992-06-03	58	0
K921645	AMSEN SPINE IMPACTOR INSTRUMENTS	Advanced Med/Surg, Inc.	1992-06-03	58	0
K921642	AMSEN DOUBLE-ENDED FORAMINAL PROBE	Advanced Med/Surg, Inc.	1992-06-03	58	0
K901521	OSTEOTOMES OF VARIOUS TYPES	Mumtaz I. Malik	1990-09-28	179	0
K901511	CHISEL, BONE, SURGICAL	Mumtaz I. Malik	1990-09-28	183	0
K901420	VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8	Mumtaz I. Malik	1990-09-28	186	0
K901289	RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS	Mumtaz I. Malik	1990-09-28	192	0
K902819	LAMINECTOMY ROGEUR	Ruggles Corp.	1990-08-09	43	0
K903247	ADJUSTABLE ANGLE GUIDE	Onyx Medical Corp.	1990-07-30	6	0
K903257	DRIVER/EXTRACTOR	Onyx Medical Corp.	1990-07-30	6	0
K903270	T-HANDLE HEX WRENCH	Onyx Medical Corp.	1990-07-30	6	0
K895172	KRONNER SACRAL PIN GUIDE	Kronner Medical	1989-09-12	33	0
K891903	COHN TARGETEER	Orthopedic Systems, Inc.	1989-05-15	49	0
K890156	IMPACTOR FOR FEMORAL HEAD	Dhason Brothers, Inc.	1989-02-13	35	0
K890163	AUSTIN MOORE HALLOW CHISEL	Dhason Brothers, Inc.	1989-02-13	35	0
K890168	RETRACTOR, SELF-RETAINING	Dhason Brothers, Inc.	1989-02-13	35	0
K890158	RETRACTORS	Dhason Brothers, Inc.	1989-02-13	35	0
K890162	EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD	Dhason Brothers, Inc.	1989-02-13	35	0
K890161	THOMPSON TYPE RASP W/TOMMY BAR	Dhason Brothers, Inc.	1989-02-13	35	0
K890157	FORCEPS	Dhason Brothers, Inc.	1989-02-13	35	0
K890166	RONGUER-ORTHOPEDIC	Dhason Brothers, Inc.	1989-02-13	35	0
K890164	HUDSON BRACE W/BURRS	Dhason Brothers, Inc.	1989-02-13	35	0
K890160	GOUGES FOR FEMORAL HEADS	Dhason Brothers, Inc.	1989-02-13	35	0
K883694	TENSIOMETER	W. L. Gore & Associates, Inc.	1988-11-22	85	0
K882077	MICRODISCECTOMY CURRETTES	Karlin Technology, Inc.	1988-06-17	31	0
K882069	SPINAL DISTRACTORS, SPANNERS	Karlin Technology, Inc.	1988-06-17	31	0
K880413	PATELLAR TENDON GRAFT GUIDE	Concept, Inc.	1988-03-04	32	0
K860131	ACROMED SPINAL SURGERY INSTRUMENTS	Buckman Co., Inc.	1986-03-19	64	0
K844595	ORTHOPEDIC CUSTOM SURGICAL KIT	Xanmed Corp.	1985-08-21	268	0
K843942	HENNING MENISCAL SUTURE KIT	Stryker Corp.	1985-04-15	188	0
K841970	CAMELBACK HANDLE-K841969-LABELING	Stainless Mfg., Inc.	1984-06-19	36	0
K841969	6.5MM HEX HANDLE	Stainless Mfg., Inc.	1984-06-19	36	0
K834108	NEEDLE BENDER TX8225	Today'S Machining & Design, Inc.	1984-03-12	104	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