Cleared Traditional

K061089 - MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

K061089 is an FDA 510(k) clearance for MODULAR THUMB IMPLANT, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K061089 · Biopro, Inc. · Orthopedic device
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Jun 2006
Decision
63d
Days
Class 2
Risk

K061089 is an FDA 510(k) clearance for the MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598.... Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on June 20, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biopro, Inc. devices

FDA 510(k) Submission Details - K061089

510(k) Number K061089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2006
Decision Date June 20, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYI Device Classification - Class 2, Special Controls

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KYI Prosthesis, Wrist, Carpal Trapezium

All 22
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K061089.
ARTELON STT SPACER
K061956 · Artimplant AB · Jun 2007
ARTELON CMC SPACER ARTHRO
K061954 · Artimplant AB · Jun 2007
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K061451 · Ascension Orthopedics, Inc. · Aug 2006
NEXA CARPO METACARPAL IMPLANT
K060386 · Nexa Orthopedics, Inc. · May 2006
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
K052596 · Biopro, Inc. · Nov 2005
ASCENSION PYROSPHERE (PCS)
K042690 · Ascension Orthopedics, Inc. · Nov 2004