Cleared Traditional

K041595 - TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870

K041595 is an FDA 510(k) clearance for TOE MP JOINT, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K041595 · Biopro, Inc. · Orthopedic device
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Nov 2004
Decision
151d
Days
Class 2
Risk

K041595 is an FDA 510(k) clearance for the TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867.... Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on November 12, 2004 after a review of 151 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biopro, Inc. devices

FDA 510(k) Submission Details - K041595

510(k) Number K041595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2004
Decision Date November 12, 2004
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWD Device Classification - Class 2, Special Controls

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 35
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K041595.
SBI TRIHEDRON MTP HEMI GT
K062040 · Small Bone Innovations, Inc. · Oct 2006
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · Osteomed LP · Jun 2006
ASCENSION PYROSPHERE CMC/TMT
K060560 · Ascension Orthopedics, Inc. · May 2006
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · Arthrosurface, Inc. · Feb 2004
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc · Nov 2003
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · Kinetikos Medical, Inc. · Dec 2002