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STABLYX CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5

by Skeletal Dynamics, LLC

510(k) K111068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111068 Date30 Dec 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KYI
Models / Variants
2
3
4
5
Device Class
Class II
Regulation
21 CFR Part 888.3770
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The STABLYX CMC Arthroplasty Implant is a prosthesis for the wrist, carpal trapezium, designed to replace the proximal end of the first metacarpal. It is intended for cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation or bone loss presenting as a painful, unstable thumb or a thumb with limited range of motion.

The device is supplied in sizes 1, 2, 3, 4, and 5. It received FDA 510(k) clearance under K111068 and is classified as a Class II device under regulation number 888.3770 with product code KYI. The implant is used in orthopedic settings and is manufactured by Skeletal Dynamics, LLC.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the STABLYX CMC Arthroplasty Implant used for?

    It is a prosthesis designed to replace the proximal end of the first metacarpal in the wrist, carpal trapezium joint. It treats painful, unstable thumbs or limited range of motion caused by rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture bone loss or deformation.

  • How is the STABLYX CMC Arthroplasty Implant supplied and what sizes are available?

    The implant is supplied in five distinct sizes: 1, 2, 3, 4, and 5. Each size corresponds to different anatomical dimensions to match patient variability in thumb joint reconstruction.

  • Is the STABLYX CMC Arthroplasty Implant reusable or single-use?

    The device is intended for single-use implantation. As a permanent orthopedic prosthesis, it is implanted during surgery and remains in the body; it is not designed to be removed, reprocessed, or reused.

  • What regulatory pathway was used for the STABLYX CMC Arthroplasty Implant?

    The device received FDA 510(k) clearance under submission number K111068, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation 888.3770 with product code KYI.