Cleared Traditional

K202639 - si-Mochi

K202639 is an FDA 510(k) clearance for si-Mochi, manufactured by Biostone, Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K202639 · Biostone, Ltd. · Orthopedic device
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Apr 2021
Decision
222d
Days
Class 2
Risk

K202639 is an FDA 510(k) clearance for the si-Mochi. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biostone, Ltd. (Nottingham, GB). The FDA issued a Cleared decision on April 21, 2021 after a review of 222 days - an extended review cycle.

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: 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 Biostone, Ltd. devices

FDA 510(k) Submission Details - K202639

510(k) Number K202639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2020
Decision Date April 21, 2021
Days to Decision 222 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
100d slower than avg
Panel avg: 122d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 291
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K202639.
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