Cleared Traditional

K971047 - FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT

K971047 is an FDA 510(k) clearance for FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT, manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K971047 · Nexa Orthopedics, Inc. · Orthopedic device
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Jun 1997
Decision
91d
Days
Class 2
Risk

K971047 is an FDA 510(k) clearance for the FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 91 days - within the typical 510(k) review window.

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 Nexa Orthopedics, Inc. devices

FDA 510(k) Submission Details - K971047

510(k) Number K971047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1997
Decision Date June 20, 1997
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 28
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K971047.
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
TOWNLEY GREAT TOE JOINT
K911378 · Biopro, Inc. · Nov 1991
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · Dow Corning Wright · Apr 1987
IMPLANT, H.P. CONDYLAR
K781870 · Dow Corning Corp. Healthcare Industries Materials · Feb 1979