Cleared Traditional

K220142 - BRM Digitalis Spacer (FDA 510(k) Clearance)

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

K220142 · Brm Extremities Srl · Orthopedic device
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Apr 2023
Decision
441d
Days
Class 2
Risk

K220142 is an FDA 510(k) clearance for the BRM Digitalis Spacer. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Brm Extremities Srl (Civate, IT). The FDA issued a Cleared decision on April 4, 2023 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - 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 Brm Extremities Srl devices

Submission Details

510(k) Number K220142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date April 04, 2023
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
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

Mcra, LLC
Margeaux Rogers

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.