Cleared Traditional

K042690 - ASCENSION PYROSPHERE (PCS)

K042690 is an FDA 510(k) clearance for ASCENSION PYROSPHERE (PCS), manufactured by Ascension Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K042690 · Ascension Orthopedics, Inc. · Orthopedic device
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Nov 2004
Decision
45d
Days
Class 2
Risk

K042690 is an FDA 510(k) clearance for the ASCENSION PYROSPHERE (PCS). Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on November 13, 2004 after a review of 45 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 Ascension Orthopedics, Inc. devices

FDA 510(k) Submission Details - K042690

510(k) Number K042690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date November 13, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
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 14
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K042690.
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K061451 · Ascension Orthopedics, Inc. · Aug 2006
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
K061089 · Biopro, Inc. · Jun 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 PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
K041451 · Ascension Orthopedics, Inc. · Aug 2004
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997