Cleared Traditional

K052624 - INION OTPS BIODEGRADABLE DISTAL RADIUS ...

K052624 is an FDA 510(k) clearance for INION OTPS BIODEGRADABLE DISTAL RADIUS ..., manufactured by Inion , Ltd.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K052624 · Inion , Ltd. · Orthopedic device
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Nov 2005
Decision
54d
Days
Class 2
Risk

K052624 is an FDA 510(k) clearance for the INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on November 16, 2005 after a review of 54 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 Inion , Ltd. devices

FDA 510(k) Submission Details - K052624

510(k) Number K052624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2005
Decision Date November 16, 2005
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K052624.
TRIMED BONE PLATES
K060041 · TriMed, Inc. · Feb 2006
ARTHREX TENSIONLOK
K052901 · Arthrex, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041 · Collagen Matrix, Inc. · Oct 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · Synthes (Usa) · Oct 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390 · Synthes (Usa) · Oct 2005