Home / 510(k) Clearances / K233670

510(k) K233670

Ascension Silicone MCP; Ascension Silicone PIP by Ascension Orthopedics, Inc. — Product Code KYJ

K233670 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "Ascension Silicone MCP; Ascension Silicone PIP". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
November 15, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Finger, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3230
Review Panel
OR
Submission Type

Other clearances by Ascension Orthopedics, Inc.

  • K233674 — Freedom Wrist Arthroplasty System (May 30, 2024)
  • K182878 — Integra Salto Total Ankle System (December 18, 2018)
  • K162153 — Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (July 14, 2017)
  • K160830 — Integra External Fixation System (July 6, 2016)
  • K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (December 23, 2015)
  • K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System (October 29, 2015)
  • K151459 — Integra Total Ankle Replacement System (August 31, 2015)
  • K142413 — TITAN Modular Total Shoulder System (November 14, 2014)
  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)
  • K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM (December 6, 2011)

Other clearances for product code KYJ

  • K220142 — BRM Digitalis Spacer (April 4, 2023)
  • K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses (July 27, 2022)
  • K140453 — OSTEOTEC SILICONE FINGER IMPLANT (April 17, 2015)
  • K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER (February 9, 2009)
  • K082231 — ASCENSION SILICONE PIP (January 12, 2009)
  • K022892 — ASCENSION SILLICONE MCP (November 25, 2002)
  • K013629 — FINGER JOINT PROSTHESIS (January 25, 2002)
  • K001922 — DEPUY NEUFLEX PIP FINGER (August 29, 2000)
  • K970544 — DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (September 12, 1997)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)

FDA data resources