Cleared Traditional

OMNI-FIX, HUMERAL NAIL (K991405) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991405 · Turnkey Intergration USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
68d
Days
Class 2
Risk

K991405 is an FDA 510(k) clearance for the OMNI-FIX, HUMERAL NAIL. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Sarasota, US). The FDA issued a Cleared decision on June 29, 1999 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Turnkey Intergration USA, Inc. devices

Submission Details

510(k) Number K991405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1999
Decision Date June 29, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 15
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K991405.
STRYKER TRAUMA PELVIC SET
K001614 · Howmedica Osteonics Corp. · Aug 2000
SAMARCO SPIDER PLATES
K001271 · Biomet, Inc. · Jul 2000
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
K992837 · Synthes (Usa) · Oct 1999
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · Wrightmedicaltechnologyinc · Sep 1998
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · Synthes (Usa) · Nov 1995
TORUS EXTERNAL FIXATION SYSTEM
K925635 · Zimmer, Inc. · Jun 1993