Cleared Traditional

K955848 - ORTHOFIX MODULSYSTEM

K955848 is the FDA 510(k) clearance for ORTHOFIX MODULSYSTEM by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K955848 · Orthofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
84d
Days
Class 2
Risk

K955848 is an FDA 510(k) clearance for the ORTHOFIX MODULSYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Orthofix, Inc. (Rockville, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 84 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 Orthofix, Inc. devices

Submission Details

510(k) Number K955848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1995
Decision Date March 20, 1996
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K955848.
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · Synthes (Usa) · Mar 1997
HANSSON PIN SYSTEM
K964893 · Osteonics Corp. · Feb 1997
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973 · Depuy, Inc. · Dec 1996
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K955780 · Zimmer, Inc. · Feb 1996
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630 · Depuy, Inc. · Dec 1995
CANNULATED PLUS HIP SCREW
K952640 · Wrightmedicaltechnologyinc · Jul 1995