Cleared Traditional

K061531 - SPACE CPSXL BONE CEMENT

K061531 is an FDA 510(k) clearance for SPACE CPSXL BONE CEMENT, manufactured by Dfine, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K061531 · Dfine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
89d
Days
Class 2
Risk

K061531 is an FDA 510(k) clearance for the SPACE CPSXL BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Dfine, Inc. (Cupertino, US). The FDA issued a Cleared decision on August 30, 2006 after a review of 89 days - a notably fast clearance cycle.

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: 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 Dfine, Inc. devices

FDA 510(k) Submission Details - K061531

510(k) Number K061531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date August 30, 2006
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K061531.
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K060425 · Arthrocare Corp. · Jul 2006
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K053336 · Spine Wave, Inc. · Jul 2006
CONFIDENCE HIGH VISCOSITY BONE CEMENT
K060300 · Disc-O-Tech Medical Technologies, Ltd. · Jun 2006