510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140453Substantially Equivalent

Osteotec Silicone Finger Implant

Osteotec Limited, Christchurch, Dorset, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140453 is the FDA 510(k) clearance record for OSTEOTEC SILICONE FINGER IMPLANT, a class II device, cleared for Osteotec, Ltd. on under FDA product code KYJ (Prosthesis, Finger, Constrained, Polymer). FDA records list one 510(k) clearance for Osteotec, Ltd. As of , FDA records show one recall naming K140453.

Clearance record

Decision date
Received
(417 days to decision)
Product code
KYJ Prosthesis, Finger, Constrained, Polymer
Regulation
21 CFR 888.3230
Device class
Class II
Review panel
Orthopedic
Applicant
Osteotec, Ltd. 9 Silver Business Park, Airfield Way, Christchurch, Dorset, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYJ

Trailing 12 months

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

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