Cleared Traditional

K093477 - SHIELD KYPHOPLASTY SYSTEM

K093477 is an FDA 510(k) clearance for SHIELD KYPHOPLASTY SYSTEM, manufactured by Soteira, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 759-day FDA review.

K093477 · Soteira, Inc. · Orthopedic device
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Dec 2011
Decision
759d
Days
Class 2
Risk

K093477 is an FDA 510(k) clearance for the SHIELD KYPHOPLASTY SYSTEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Soteira, Inc. (Ayer, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 759 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Soteira, Inc. devices

FDA 510(k) Submission Details - K093477

510(k) Number K093477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2009
Decision Date December 08, 2011
Days to Decision 759 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
637d slower than avg
Panel avg: 122d · This submission: 759d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 57
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