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510(k) K042690

ASCENSION PYROSPHERE (PCS) by Ascension Orthopedics, Inc. — Product Code KYI

K042690 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION PYROSPHERE (PCS)". The FDA issued a decision of Substantially Equivalent on November 13, 2004. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
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 KYI

  • K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (December 2, 2020)
  • K180744 — Stablyx CMC Arthroplasty Implant System (April 11, 2018)
  • K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 (December 30, 2011)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS (December 15, 2009)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K061451 — ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (August 11, 2006)
  • K061089 — MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 (June 20, 2006)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)

FDA data resources