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FDA 510(k)

Stablyx CMC Arthroplasty Implant System

K-Number: K180744 · 2018-04-11

ApplicantSkeletal Dynamics, LLC
Decision Date2018-04-11
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stablyx CMC Arthroplasty Implant System is a medical device manufactured by Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2018-04-11 under approval number K180744. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stablyx CMC Arthroplasty Implant System?

Stablyx CMC Arthroplasty Implant System is a medical device that received FDA 510(k) clearance on 2018-04-11. It is manufactured by Skeletal Dynamics, LLC. The 510(k) number is K180744.

When was Stablyx CMC Arthroplasty Implant System approved by the FDA?

Stablyx CMC Arthroplasty Implant System received FDA 510(k) clearance on 2018-04-11, under approval number K180744.

What company makes Stablyx CMC Arthroplasty Implant System?

Stablyx CMC Arthroplasty Implant System is manufactured by Skeletal Dynamics, LLC.

What is the FDA product code for Stablyx CMC Arthroplasty Implant System?

The FDA product code for Stablyx CMC Arthroplasty Implant System is KYI.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Skeletal Dynamics, LLC

K172688Align Radial Head System K171590Distal Elbow Plating System K182492Geminus Volar Distal Radius Plate System

Related Devices (Code: KYI)

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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