Cleared Traditional

K010555 - JAX

K010555 is the FDA 510(k) clearance for JAX by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 729-day FDA review.

K010555 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2003
Decision
729d
Days
Class 2
Risk

K010555 is an FDA 510(k) clearance for the JAX. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 25, 2003 after a review of 729 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K010555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date February 25, 2003
Days to Decision 729 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
607d slower than avg
Panel avg: 122d · This submission: 729d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K010555.
MASTERGRAFT MATRIX
K023553 · Medtronic Sofamor Danek, Inc. · Apr 2003
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K024336 · Wrightmedicaltechnologyinc · Mar 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · Synthes (Usa) · Dec 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · Wrightmedicaltechnologyinc · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002