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

Poly-Medics,Inc. — Predicate Candidate Screening

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

106 daysmedian FDA review time

388 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960988	LACTOSORB TRAUMA PLATING SYSTEM	Poly-Medics,Inc.	1996-04-10	34	0
K955729	LACTOSORB TRAUMA PLATING SYSTEM	Poly-Medics,Inc.	1996-02-14	58	1
K954443	LACTOSORB SUTURE ANCHOR	Poly-Medics,Inc.	1996-01-31	128	0
K951658	LACTOSORB POP RIVET	Poly-Medics,Inc.	1995-07-25	106	0
K934861	HARD TISSUE REPLACEMENT (HTR) GRANULAR	Poly-Medics,Inc.	1994-11-04	388	0

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