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

Parcus Medical, LLC — Predicate Candidate Screening

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

88 daysmedian FDA review time

161 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K221502	Parcus Synd-EZ SS	Parcus Medical, LLC	2022-07-26	64
K221135	X-Twist PEEK Suture Anchor	Parcus Medical, LLC	2022-05-19	30
K212739	ActiFlip	Parcus Medical, LLC	2021-10-06	37
K202662	Parcus Titanium Interference Screws	Parcus Medical, LLC	2021-02-22	161
K202259	Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB	Parcus Medical, LLC	2020-10-28	79
K201083	Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anc	Parcus Medical, LLC	2020-07-23	91
K193295	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	Parcus Medical, LLC	2020-01-23	57
K192750	AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate	Parcus Medical, LLC	2020-01-16	108
K192964	Parcus Synd-EZ SS	Parcus Medical, LLC	2019-11-22	30
K192824	Parcus Knotless AP Suture Anchors	Parcus Medical, LLC	2019-11-02	31
K191783	Parcus Synd-EZ Ti	Parcus Medical, LLC	2019-10-09	98
K190375	Parcus ATLAS	Parcus Medical, LLC	2019-04-24	64
K183501	Parcus Twist AP Suture Anchors	Parcus Medical, LLC	2019-03-15	88
K183331	Parcus GFS BTB	Parcus Medical, LLC	2019-02-07	66
K162198	GFS Ultimate	Parcus Medical, LLC	2016-11-18	105
K152711	Parcus GFS Naked	Parcus Medical, LLC	2015-11-20	60
K133757	GFS II STANDARD, GFS II LARGE, GFS MIMI	Parcus Medical, LLC	2014-02-04	55
K122805	PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR	Parcus Medical, LLC	2013-02-05	145
K120942	PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PE	Parcus Medical, LLC	2012-04-20	22
K113730	PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45	Parcus Medical, LLC	2012-01-17	29
K111000	PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR	Parcus Medical, LLC	2011-07-28	108
K102326	PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR	Parcus Medical, LLC	2010-11-15	90
K102162	PARCUS PEEK CF PUSH-IN SUTURE ANCHOR	Parcus Medical, LLC	2010-11-10	100
K091093	PARCUS PPEK CF INTERFERENCE SCREW	Parcus Medical, LLC	2009-09-30	167
K091094	PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10	Parcus Medical, LLC	2009-09-30	167
K090923	PARCUS GRAFT FIXATION SYSTEM	Parcus Medical, LLC	2009-06-30	90
K083619	PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10	Parcus Medical, LLC	2009-03-06	88
K090075	PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10	Parcus Medical, LLC	2009-03-06	53

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