Cleared Traditional

K981194 - FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT

K981194 is an FDA 510(k) clearance for FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IM..., manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K981194 · Nexa Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
89d
Days
Class 2
Risk

K981194 is an FDA 510(k) clearance for the FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT. Classified as Prosthesis, Toe, Constrained, Polymer (product code KWH), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 30, 1998 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3720 - 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 Nexa Orthopedics, Inc. devices

FDA 510(k) Submission Details - K981194

510(k) Number K981194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date June 30, 1998
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWH Device Classification - Class 2, Special Controls

Product Code KWH Prosthesis, Toe, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3720
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 - KWH Prosthesis, Toe, Constrained, Polymer

All 14
Devices cleared under the same product code (KWH) and FDA review panel - the closest regulatory comparables to K981194.
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · Nexa Orthopedics, Inc. · Nov 2002
CLASSIC GREAT TOE IMPLANT
K023086 · Nexa Orthopedics, Inc. · Oct 2002
ASCENT KNEE SYSTEM
K994326 · Biomet Manufacturing, Inc. · Jan 2000
PROFIX CONFORMING PLUS TIBIAL INSERT
K946236 · Smith & Nephew Richards, Inc. · Jul 1995
ZIMMER GREAT TOE
K823405 · Zimmer, Inc. · Jan 1983
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
K801094 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980