Cleared Traditional

K253118 - Companion Spine DIAM™ Instrumentation (FDA 510(k) Clearance)

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

K253118 · Companion Spine France · Orthopedic device
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Dec 2025
Decision
83d
Days
Class 2
Risk

K253118 is an FDA 510(k) clearance for the Companion Spine DIAM™ Instrumentation. Classified as Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices (product code QLR), Class II - Special Controls.

Submitted by Companion Spine France (Mérignac, FR). The FDA issued a Cleared decision on December 16, 2025 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4520 - 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 Companion Spine France devices

Submission Details

510(k) Number K253118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2025
Decision Date December 16, 2025
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLR Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4520
Definition The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Placement, Or Removal Of Spinous Process Spacer Devices For Non-fusion Use.
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
Lucas Tatem

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.