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510(k) K061089

MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 by Biopro, Inc. — Product Code KYI

K061089 is an FDA 510(k) premarket notification submitted by Biopro, Inc. for the device "MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599". The FDA issued a decision of Substantially Equivalent on June 20, 2006. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Biopro, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2006
Date Received
April 18, 2006
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 Biopro, Inc.

  • K163627 — Shotel Ankle Arthrodesis Nail System (September 14, 2017)
  • K162674 — BioPro Foot Plating Systems (June 16, 2017)
  • K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM (October 24, 2013)
  • K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM (June 18, 2013)
  • K121973 — BIOPRO HEMI-EDGE TOE SYSTEM (October 30, 2012)
  • K100761 — BIOPRO POLAR HEAD (December 3, 2010)
  • K101030 — MODIFICATION TO HBS HEADLESS BONE SCREW (June 3, 2010)
  • K090208 — BIOPRO FEMORAL HEADS (May 22, 2009)
  • K083490 — BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 (March 18, 2009)
  • K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (December 15, 2008)

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)
  • K060386 — NEXA CARPO METACARPAL IMPLANT (May 10, 2006)
  • K052596 — MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17 (November 15, 2005)

FDA data resources