Cleared Traditional

K231699 - QUANTUM® Patient Specific Instrumentation (PSI) System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231699 · In2bones Sas · Orthopedic device
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Apr 2024
Decision
316d
Days
Class 2
Risk

K231699 is an FDA 510(k) clearance for the QUANTUM® Patient Specific Instrumentation (PSI) System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on April 23, 2024 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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. Elevated predicate reliance profile. 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 In2bones Sas devices

Submission Details

510(k) Number K231699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2023
Decision Date April 23, 2024
Days to Decision 316 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
194d slower than avg
Panel avg: 122d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 Consultant

In2bones USA
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 66
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K231699.
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K242868 · Restor3d · Oct 2024