Cleared Traditional

K122533 - OSSEOFLEX SB INFLATABLE BONE TAMP

K122533 is an FDA 510(k) clearance for OSSEOFLEX SB INFLATABLE BONE TAMP, manufactured by Osseon Therapeutics, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K122533 · Osseon Therapeutics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
64d
Days
Class 2
Risk

K122533 is an FDA 510(k) clearance for the OSSEOFLEX SB INFLATABLE BONE TAMP. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Osseon Therapeutics, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 64 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.

FDA 510(k) Submission Details - K122533

510(k) Number K122533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2012
Decision Date October 23, 2012
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K122533.
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K121876 · Aap Biomaterials GmbH · Oct 2012
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K113742 · Shanghai Kinetic Medical Co., Ltd. · Sep 2012
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K113452 · Ascendx Spine, Inc. · Feb 2012
K122533 · OSSEOFLEX SB INFLATABLE BONE TAMP
Download PDF FDA Summary Osseon Therapeutics, …