510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153609Substantially Equivalent

RTS Flexible 1 MPJ Implant w/Grommets

In2bones USA, LLC, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153609 is the FDA 510(k) clearance record for RTS Flexible 1 MPJ Implant w/Grommets, a class II device, cleared for In2bones USA, LLC on under FDA product code KWH (Prosthesis, Toe, Constrained, Polymer). FDA records list 27 510(k) clearances for In2bones USA, LLC, from to . As of , FDA records show no recalls naming K153609.

Clearance record

Decision date
Received
(266 days to decision)
Product code
KWH Prosthesis, Toe, Constrained, Polymer
Regulation
21 CFR 888.3720
Device class
Class II
Review panel
Orthopedic
Applicant
In2bones USA, LLC 6060 Poplar Ave., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWH

Trailing 12 months

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

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