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510(k) K102549

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY by Ascension Orthopedics, Inc. — Product Code LZJ

K102549 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
September 7, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Ascension Orthopedics, Inc.

  • K233674 — Freedom Wrist Arthroplasty System (May 30, 2024)
  • K233670 — Ascension Silicone MCP; Ascension Silicone PIP (December 14, 2023)
  • 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)

Other clearances for product code LZJ

  • K132496 — ARTHROSURFACE TOEMOTION (February 26, 2014)
  • K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (May 8, 2008)
  • K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (July 31, 1995)
  • K941650 — TOTAL TOE SYSTEM II (December 19, 1994)
  • K924724 — KINETIK GREAT TOE SYSTEM (January 5, 1994)
  • K922211 — OSTEOMED GREAT TOE SYSTEM (November 9, 1993)
  • K920446 — TOTAL TOE SYSTEM (March 22, 1993)
  • K920667 — GREAT TOE IMPLANT (June 19, 1992)
  • K911552 — ANATOMIC TOE SYSTEM (June 28, 1991)
  • K884561 — KOENIG TOTAL TOE IMPLANT (January 24, 1989)

FDA data resources