Cleared Traditional

K003033 - SCAPHIX

K003033 is an FDA 510(k) clearance for SCAPHIX, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K003033 · Avanta Orthopaedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
244d
Days
Class 2
Risk

K003033 is an FDA 510(k) clearance for the SCAPHIX, STAPLE, FIXATION, BONE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 244 days - an extended review 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: 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K003033

510(k) Number K003033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2000
Decision Date May 30, 2001
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 141
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K003033.
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · Smith & Nephew, Inc. · Oct 2002
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc. · Oct 2001
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A. · Aug 2001
SOLUSTAPLE
K991566 · New Deal, S.A. · Aug 1999
UNI-CLIP STAPLE
K991482 · New Deal, S.A. · Jun 1999
MITEK MICRO ANCHOR
K982420 · Mitek Products · Aug 1998