Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Jeil Medical Corporation · Predicate Candidate Screening

53 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

136 daysmedian FDA review time

258 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days
K252246	Leforte MMF System	Jeil Medical Corporation	2026-04-02	258
K252826	ARIX Femur Nail System	Jeil Medical Corporation	2025-12-10	96
K251431	FIX-C PEEK ACIF SA System	Jeil Medical Corporation	2025-06-27	50
K243973	FIX-L PEEK PLIF and T-PLIF System	Jeil Medical Corporation	2025-06-12	171
K242751	ARIX Pectus Bar System	Jeil Medical Corporation	2025-05-30	260
K242247	ARIX Femur Nail System	Jeil Medical Corporation	2025-04-22	265
K243915	FIX-C 3D Ti ACIF System	Jeil Medical Corporation	2025-02-18	60
K243004	Xpine Spinal Fixation System	Jeil Medical Corporation	2024-11-08	43
K231251	FlexWing Anterior Cervical Plate System	Jeil Medical Corporation	2024-07-24	450
K233912	ARIX Cannulated Screw System	Jeil Medical Corporation	2024-03-11	90
K231887	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	2023-12-14	170
K231441	ARIX Ankle System	Jeil Medical Corporation	2023-07-17	60
K230938	ARIX Humerus System	Jeil Medical Corporation	2023-05-03	30
K221412	ARIX Rib System	Jeil Medical Corporation	2022-11-22	190
K221920	ARIX Small Fragment System	Jeil Medical Corporation	2022-08-24	54
K212266	FIX-C PEEK Anterior Cervical Interbody System	Jeil Medical Corporation	2021-12-21	154
K202912	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	2020-10-29	30
K201656	ARIX Elbow System	Jeil Medical Corporation	2020-09-15	89
K193616	ARIX Ankle System	Jeil Medical Corporation	2020-03-04	69
K192417	ARIX Cannulated Screw System	Jeil Medical Corporation	2019-11-26	83
K191972	ARIX Wrist System	Jeil Medical Corporation	2019-11-12	111
K181806	ARIX Sternal System	Jeil Medical Corporation	2018-11-20	137
K180972	ARIX Clavicle System	Jeil Medical Corporation	2018-10-03	173
K172008	ARIX Humerus System	Jeil Medical Corporation	2017-12-01	151
K170705	ARIX Wrist System	Jeil Medical Corporation	2017-09-21	197
K170368	Sterile NS System	Jeil Medical Corporation	2017-09-11	217
K170979	ARIX Ankle Fibula Hook Plate System	Jeil Medical Corporation	2017-08-17	136
K170780	ARIX Foot System (2.3/2.8)	Jeil Medical Corporation	2017-08-14	152
K170313	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	2017-07-27	176
K171285	ARIX Diaphysis System	Jeil Medical Corporation	2017-07-24	84
K161335	Dual Top Screw System	Jeil Medical Corporation	2017-02-23	287
K163308	SMARTO	Jeil Medical Corporation	2016-12-27	34
K161746	ARIX Hand System	Jeil Medical Corporation	2016-09-21	89
K161864	ARIX Foot System	Jeil Medical Corporation	2016-08-02	26
K151468	ARIX Wrist System	Jeil Medical Corporation	2016-01-14	227
K152158	ARIX Ankle System	Jeil Medical Corporation	2015-09-28	56
K150965	LeForte System II	Jeil Medical Corporation	2015-09-17	160
K143730	GBR System	Jeil Medical Corporation	2015-06-10	163
K130447	SPEEDY FLAP SYSTEM	Jeil Medical Corporation	2014-12-22	669
K141452	LEFORTE NEURO SYSTEM BONE PLATE AND SCREW	Jeil Medical Corporation	2014-07-02	30
K132876	ARIX HAND LOCKING SYSTEM	Jeil Medical Corporation	2013-12-18	96
K131566	ARIX HAND SYSTEM	Jeil Medical Corporation	2013-11-04	158
K131311	ARIX FOOT SYSTEM	Jeil Medical Corporation	2013-09-05	121
K112812	LEFORTE NEURO SYSTEM BONE PLATE	Jeil Medical Corporation	2012-02-22	148
K101902	J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030	Jeil Medical Corporation	2011-02-08	215
K103778	LEFORTE NEURO SYSTEM BONE PLATE	Jeil Medical Corporation	2011-01-26	30
K101563	SMARTO	Jeil Medical Corporation	2010-12-17	196
K091686	LEFORTE NEUROSYSTEM BONE SCREW	Jeil Medical Corporation	2009-11-13	157
K091679	LEFORTE SYSTEM BONE PLATE	Jeil Medical Corporation	2009-10-02	115
K050669	JEIL BONE FIXATION SYSTEM	Jeil Medical Corporation	2005-05-26	72

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