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

Flower Orthopedics Corporation · Predicate Candidate Screening

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

94 daysmedian FDA review time

355 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192949	Flower Suture Anchor Set	Flower Orthopedics Corporation	2020-10-07	355	0
K170687	Flower Bone Screw Set	Flower Orthopedics Corporation	2017-06-06	91	0
K142306	Flower Upper Extremity Plating Set	Flower Orthopedics Corporation	2014-09-15	27	0
K133930	FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET,	Flower Orthopedics Corporation	2014-03-27	94	6
K133102	FLOWER ANKLE PLATING SET	Flower Orthopedics Corporation	2013-11-18	49	0
K132248	FLOWER BONE SCREW SET	Flower Orthopedics Corporation	2013-10-30	103	0
K131657	FLOWER SMALL AND MEDIUM IMPLANT SET	Flower Orthopedics Corporation	2013-08-22	77	1
K123562	FLOWER SMALL AND MEDIUM BONE IMPLANTS	Flower Orthopedics Corporation	2013-03-29	130	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