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

Ortho Solutions Limited — Predicate Candidate Screening

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

120 daysmedian FDA review time

264 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141784	ORTHO SOLUTIONS ULTOS PLATING SYSTEM	Ortho Solutions Limited	2014-07-23	21	2
K121575	OXFORD ANKLE FUSION NAIL(AFN) SYSTEM	Ortho Solutions Limited	2012-09-14	107	0
K120360	ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS	Ortho Solutions Limited	2012-05-29	113	0
K111678	ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHE	Ortho Solutions Limited	2012-02-07	237	0
K110895	ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS	Ortho Solutions Limited	2011-12-19	264	0
K102743	ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES	Ortho Solutions Limited	2011-01-20	120	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