Cleared Traditional

K010321 - MODULAR FOOT SYSTEM - 2.7 MM MODULE

K010321 is the FDA 510(k) clearance for MODULAR FOOT SYSTEM - 2.7 MM MODULE by Synthes (Usa). It is a Class 2 Orthopedic device (product code KTW) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K010321 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
89d
Days
Class 2
Risk

K010321 is an FDA 510(k) clearance for the MODULAR FOOT SYSTEM - 2.7 MM MODULE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K010321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date May 02, 2001
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.

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 22
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K010321.
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · Alliance Medical Corp. · Jun 2002
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa) · Sep 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · Synthes (Usa) · Aug 2001
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