510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022779Substantially Equivalent

Oti Unicondular Interpositional Spacer

Osteoimplant Technology, Inc., Hunt Valley MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022779 is the FDA 510(k) clearance record for OTI UNICONDULAR INTERPOSITIONAL SPACER, a class II device, cleared for Osteoimplant Technology, Inc. on under FDA product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)). FDA records list 21 510(k) clearances for Osteoimplant Technology, Inc., from to . As of , FDA records show no recalls naming K022779.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Regulation
21 CFR 888.3590
Device class
Class II
Review panel
Orthopedic
Applicant
Osteoimplant Technology, Inc. 11201 Pepper Rd., Hunt Valley MD
510(k) summary
Statement
Third party review
No

Clearances, product code HSH

Trailing 12 months

FDA records hold no clearances under product code HSH in the trailing twelve months.

FDA records show no clearances under product code HSH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HSH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260