Cleared Traditional

K100604 - OTIS -C PLUS

K100604 is an FDA 510(k) clearance for OTIS -C PLUS, manufactured by Sciences ET Bio Materiaux (Sbm). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K100604 · Sciences ET Bio Materiaux (Sbm) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2010
Decision
103d
Days
Class 2
Risk

K100604 is an FDA 510(k) clearance for the OTIS -C PLUS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Sciences ET Bio Materiaux (Sbm) (Lourdes, FR). The FDA issued a Cleared decision on June 14, 2010 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sciences ET Bio Materiaux (Sbm) devices

FDA 510(k) Submission Details - K100604

510(k) Number K100604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2010
Decision Date June 14, 2010
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
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 1064
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100604.
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176 · Ascension Orthopedics, Inc. · Jun 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · OrthoPediatrics Corp. · May 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · Howmedica Osteonics Corp. · May 2010
VARIAX ELBOW SYSTEM
K101056 · Howmedica Osteonics Corp. · May 2010