Cleared Traditional

K001231 - THE KALIX IMPLANT

K001231 is the FDA 510(k) clearance for THE KALIX IMPLANT by New Deal, S.A.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001231 · New Deal, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
85d
Days
Class 2
Risk

K001231 is an FDA 510(k) clearance for the THE KALIX IMPLANT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by New Deal, S.A. (Potomac, US). The FDA issued a Cleared decision on July 11, 2000 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 New Deal, S.A. devices

Submission Details

510(k) Number K001231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2000
Decision Date July 11, 2000
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 639
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K001231.
BIOLOK SCREW
K002070 · Biocomposites, Ltd. · Aug 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271 · Synthes (Usa) · Aug 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · Stryker Endoscopy · Aug 2000
BIOLOK SCREW
K993630 · Encore Orthopedics, Inc. · Apr 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080 · Howmedica Osteonics Corp. · Apr 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · Corin USA · Mar 2000