510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990712Substantially Equivalent

Osteonics Solar Shoulder Bipolar System

Howmedica Osteonics Corp, Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990712 is the FDA 510(k) clearance record for OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM, a class III device, cleared for Howmedica Osteonics Corp. on under FDA product code MJT (Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented). FDA records list 377 510(k) clearances for Howmedica Osteonics Corp., from to . As of , FDA records show no recalls naming K990712.

Clearance record

Decision date
Received
(138 days to decision)
Product code
MJT Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device class
Class III
Review panel
Unknown
Applicant
Howmedica Osteonics Corp. 59 Rte. 17 S., Allendale NJ
510(k) summary
Summary
Third party review
No

Clearances, product code MJT

Trailing 12 months

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

FDA records show no clearances under product code MJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJT, 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