510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091411Substantially Equivalent

Kneealign System

OrthAlign, Inc., Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091411 is the FDA 510(k) clearance record for KNEEALIGN SYSTEM, a class II device, cleared for Orthalign, Inc. on under FDA product code OLO (Orthopedic Stereotaxic Instrument). FDA's definition for product code OLO reads: "Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW". FDA records list 15 510(k) clearances for Orthalign, Inc., from to . As of , FDA records show no recalls naming K091411.

Clearance record

Decision date
Received
(135 days to decision)
Product code
OLO Orthopedic Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Orthalign, Inc. 338 Vista Madera, Newport Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLO

Trailing 12 months
44 clearances under product code OLO in the twelve months to October 2026, February 2026 the highest month at 10.
Show the numbers
Monthly 510(k) clearances under FDA product code OLO, trailing twelve months
MonthClearances
November 20252
December 20254
January 20262
February 202610
March 20267
April 20262
May 20265
June 20265
July 20266
August 20261
September 20260
October 20260