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

Orthalign, Inc. — Predicate Candidate Screening

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

91 daysmedian FDA review time

211 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262253	Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigat	Orthalign, Inc.	2026-07-31	29	0
K253507	Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Sm	Orthalign, Inc.	2026-06-02	211	0
K242616	Lantern® Hip	Orthalign, Inc.	2024-10-03	30	0
K200892	Harvey(R) Surgical Assistant	Orthalign, Inc.	2020-06-18	76	2
K200642	OrthAlign Plus System	Orthalign, Inc.	2020-04-10	30	0
K172462	OrthAlign Plus System	Orthalign, Inc.	2017-11-22	100	0
K171780	OrthAlign Plus System	Orthalign, Inc.	2017-07-11	26	0
K163379	KneeAlign 2 System	Orthalign, Inc.	2017-03-02	91	0
K162962	OrthAlign Plus System	Orthalign, Inc.	2017-01-23	91	0
K153237	OrthAlign Plus System	Orthalign, Inc.	2016-03-01	113	0
K140331	ORTHALIGN PLUS SYSTEM	Orthalign, Inc.	2014-06-10	120	0
K130387	ORTHOALIGN PLUS SYSTEM	Orthalign, Inc.	2013-11-08	266	0
K103829	KNEEALIGN SYSTEM	Orthalign, Inc.	2011-04-04	95	0
K093998	KNEEALIGN SYSTEM WITH REFERENCE SENSOR	Orthalign, Inc.	2010-03-22	84	0
K091411	KNEEALIGN SYSTEM	Orthalign, Inc.	2009-09-25	135	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