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

Acumed, LLC — Predicate Candidate Screening

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

88 daysmedian FDA review time

206 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252356	The Acumed Wrist Fixation System - 2.4mm Screws	Acumed, LLC	2025-08-21	23	0
K251132	The Acumed Wrist Fixation System - Plates; The Acumed Wrist	Acumed, LLC	2025-07-14	94	1
K251296	The Acumed Wrist Fixation System	Acumed, LLC	2025-06-18	54	1
K243624	Acu-Sinch Knotless Mini	Acumed, LLC	2025-01-23	59	0
K233311	Acumed Wrist Plating System	Acumed, LLC	2024-04-22	206	0
K230744	Acumed Acutrak 3 Headless Compression Screw System	Acumed, LLC	2023-06-09	84	0
K221333	Acumed Acutrak System- MR Conditional, Acumed Acturak 2 Syst	Acumed, LLC	2022-12-29	234	4
K212990	Acumed Ankle Syndesmosis Repair System	Acumed, LLC	2022-01-07	109	0
K210750	Acumed Clavicle Hook Plating System	Acumed, LLC	2021-07-15	125	0
K151886	Acumed Ankle and Small Fragment Base Set Update	Acumed, LLC	2015-10-30	113	0
K143385	Acumed Ankle Plating System	Acumed, LLC	2015-04-06	131	0
K143276	Acumed Small Bone IM Nail System	Acumed, LLC	2015-02-05	83	0
K143394	Acumed Small Fragment Base Set	Acumed, LLC	2015-01-23	58	0
K141383	ACUMED HAND FRACTURE SYSTEM	Acumed, LLC	2014-06-13	17	0
K140925	ACUMED SUTURE ANCHOR SYSTEM	Acumed, LLC	2014-05-20	39	0
K133469	ACUMED SUTURE ANCHOR SYSTEM	Acumed, LLC	2014-03-10	118	0
K132769	ACUMED HAND PLATING SYSTEM	Acumed, LLC	2014-01-06	124	0
K131636	POLARUS CONNECT	Acumed, LLC	2013-10-10	128	0
K131845	ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL H	Acumed, LLC	2013-09-30	101	0
K131764	ACUMED WRIST SPANNING PLATE	Acumed, LLC	2013-09-05	80	0
K130986	FRAG-LOC SYSTEM	Acumed, LLC	2013-07-23	105	0
K131380	ACUMED TOTALW RIST FUSION PLATING SYSTEM	Acumed, LLC	2013-06-10	27	0
K123890	ACUMED CANNULATED SCREW SYSTEM	Acumed, LLC	2013-03-18	90	0
K122538	ACUMED PELVIC BONE PLATE SYSTEM	Acumed, LLC	2012-11-19	90	1
K120903	CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE	Acumed, LLC	2012-07-13	109	0
K112111	ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR	Acumed, LLC	2011-11-14	112	0
K111608	SLIC SCREW REPAIR SYSTEM	Acumed, LLC	2011-08-29	81	0
K102998	CONGRUENT BONE PLATE SYSTEM	Acumed, LLC	2011-01-04	88	0
K100123	ACUMED WRIST ARTHRODESIS PLATE SYSTEM	Acumed, LLC	2010-10-06	264	0
K083144	ACUMED CLAVICLE SCREW SYSTEM	Acumed, LLC	2009-06-16	236	0
K071944	ACUMED SMALL BONE LOCKING SYSTEM II	Acumed, LLC	2007-08-09	27	0
K071715	ACUMED CONGRUENT BONE PLATE SYSTEM	Acumed, LLC	2007-07-18	26	0
K063460	ACUMED CONGRUENT BONE PLATE SYSTEM	Acumed, LLC	2006-12-07	22	0
K051410	ACUMED RIB CONGRIENT BONE PLATE SYSTEM	Acumed, LLC	2005-07-21	51	1
K051083	ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM	Acumed, LLC	2005-05-12	15	0
K041858	ACUMED ANATOMIC RADIAL HEAD SYSTEM	Acumed, LLC	2004-10-05	88	0
K033639	ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM	Acumed, LLC	2004-01-15	56	10
K031438	ACUMED SMALL BONE LOCKING ROD SYSTEM II	Acumed, LLC	2003-07-17	72	1

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