Cleared Traditional

K030900 - INION OTPS BIODEGRADABLE FIXATON SYSTEM

K030900 is an FDA 510(k) clearance for INION OTPS BIODEGRADABLE FIXATON SYSTEM, manufactured by Inion , Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K030900 · Inion , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
87d
Days
Class 2
Risk

K030900 is an FDA 510(k) clearance for the INION OTPS BIODEGRADABLE FIXATON SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on June 19, 2003 after a review of 87 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 Inion , Ltd. devices

FDA 510(k) Submission Details - K030900

510(k) Number K030900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date June 19, 2003
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K030900.
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · Walter Lorenz Surgical, Inc. · Jun 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · Karl Storz Endoscopy · Jun 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · Inion , Ltd. · May 2003
LEFORTE SYSTEM BONE SCREW
K023365 · Jeil Medical Corporation · Apr 2003