510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K111068Substantially Equivalent

Stablyx Cmc Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5

Skeletal Dynamics, Inc, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111068 is the FDA 510(k) clearance record for STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5, a class II device, cleared for Skeletal Dynamics, LLC on under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium). FDA records list 40 510(k) clearances for Skeletal Dynamics, LLC, from to . As of , FDA records show no recalls naming K111068.

Clearance record

Decision date
Received
(256 days to decision)
Product code
KYI Prosthesis, Wrist, Carpal Trapezium
Regulation
21 CFR 888.3770
Device class
Class II
Review panel
Orthopedic
Applicant
Skeletal Dynamics, LLC 8905 SW 87 Ave., Suite 201, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYI

Trailing 12 months

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

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