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

Onyx Medical Corp. · Predicate Candidate Screening

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

16 daysmedian FDA review time

385 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days
K942022	FACE-IT SHIELD	Onyx Medical Corp.	1994-07-08	73
K931690	SPOON PLATE	Onyx Medical Corp.	1994-06-07	428
K931692	T-PLATE	Onyx Medical Corp.	1994-05-04	394
K931680	CANNULATED CANCELLOUS SCREW	Onyx Medical Corp.	1994-05-04	394
K934614	MINI FRAGMENT PLATE	Onyx Medical Corp.	1994-05-04	219
K931684	EPIPHYSIS PLATE	Onyx Medical Corp.	1994-05-04	394
K931688	SEMI-TUBULAR PLATE	Onyx Medical Corp.	1994-04-25	385
K931691	STRAIGHT MINI-PLATE	Onyx Medical Corp.	1994-04-25	385
K931683	CLOVERLEAF PLATE	Onyx Medical Corp.	1994-04-25	385
K931790	CORTICAL BONE SCREW	Onyx Medical Corp.	1994-04-25	378
K931694	1/4 TUBULAR PLATE	Onyx Medical Corp.	1994-04-25	385
K931689	SMALL STRAIGHT PLATE	Onyx Medical Corp.	1994-04-25	385
K931687	MULTIPLE FRAGMENT PLATE	Onyx Medical Corp.	1994-04-25	385
K934615	CANCELLOUS BONE SCREW	Onyx Medical Corp.	1994-04-25	210
K931693	1/3 TUBULAR PLATE	Onyx Medical Corp.	1994-04-25	385
K931679	BUTTRESS PLATE	Onyx Medical Corp.	1994-04-25	385
K931685	FOREARM SELF COMPRESSION PLATE	Onyx Medical Corp.	1994-04-25	385
K931681	CANNULATED NAVICULAR SCREW	Onyx Medical Corp.	1994-04-25	385
K934616	CANCELLOUS BONE SCREW	Onyx Medical Corp.	1994-04-25	210
K931686	MALLEOLAR SCREW	Onyx Medical Corp.	1994-04-05	365
K931682	CANNULATED MALLEOLAR SCREW	Onyx Medical Corp.	1994-04-05	365
K903254	U.S. TYPE CRUCIATE SLOT BONE SCREW	Onyx Medical Corp.	1990-08-09	16
K903255	CORTICAL BONE SCREW (EUROPEAN STYLE)	Onyx Medical Corp.	1990-08-09	16
K903259	KNOWLES PIN	Onyx Medical Corp.	1990-08-09	16
K903258	HAGIE PIN	Onyx Medical Corp.	1990-08-09	16
K903253	CANCELLOUS SCREW	Onyx Medical Corp.	1990-08-09	16
K903022	FIXATION STAPLE	Onyx Medical Corp.	1990-08-09	30
K903252	BROAD SELF-COMPRESSING PLATE	Onyx Medical Corp.	1990-08-09	16
K903266	STEINMAN PIN, THREAD	Onyx Medical Corp.	1990-07-30	6
K903247	ADJUSTABLE ANGLE GUIDE	Onyx Medical Corp.	1990-07-30	6
K903265	STEINMAN PIN	Onyx Medical Corp.	1990-07-30	6
K903264	K-WIRE	Onyx Medical Corp.	1990-07-30	6
K903256	HANSEN-STREET TYPE INTRAMEDULLARY NAIL	Onyx Medical Corp.	1990-07-30	6
K903251	JEWETT HIP NAIL	Onyx Medical Corp.	1990-07-30	6
K903273	BARBED SQUARE STAPLE	Onyx Medical Corp.	1990-07-30	6
K903242	ACETABULAR CUP	Onyx Medical Corp.	1990-07-30	6
K903250	BLADE PLATE	Onyx Medical Corp.	1990-07-30	6
K903257	DRIVER/EXTRACTOR	Onyx Medical Corp.	1990-07-30	6
K903244	LAG SCREW	Onyx Medical Corp.	1990-07-30	6
K903246	SIDE PLATE	Onyx Medical Corp.	1990-07-30	6
K903270	T-HANDLE HEX WRENCH	Onyx Medical Corp.	1990-07-30	6
K903271	ROUND STAPLE	Onyx Medical Corp.	1990-07-30	6
K903248	COMBINATION REAMER	Onyx Medical Corp.	1990-07-30	6
K903243	MULLER-TYPE FEMORAL COMPONENT	Onyx Medical Corp.	1990-07-30	6
K903261	RUSH PIN	Onyx Medical Corp.	1990-07-30	6
K903241	AUSTIN MOORE TYPE HIP PROSTHESIS	Onyx Medical Corp.	1990-07-30	6
K903240	THOMPSON TYPE HIS PROSTHESIS	Onyx Medical Corp.	1990-07-30	6

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