Cleared Traditional

K253392 - Synergy Disc Instruments (FDA 510(k) Clearance)

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

K253392 · Synergy Spine Solutions, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
178d
Days
Class 2
Risk

K253392 is an FDA 510(k) clearance for the Synergy Disc Instruments. Classified as Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ), Class II - Special Controls.

Submitted by Synergy Spine Solutions, Inc. (Louisville, US). The FDA issued a Cleared decision on March 27, 2026 after a review of 178 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4515 - 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 Synergy Spine Solutions, Inc. devices

Submission Details

510(k) Number K253392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date March 27, 2026
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4515
Definition The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices.
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
Veronica Downen

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 - QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices

All 7
Devices cleared under the same product code (QLQ) and FDA review panel - the closest regulatory comparables to K253392.
prodisc® L Instruments
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prodisc® L Instruments
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K231769 · Aesculap Implants Systems, LLC · Jul 2023
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848 · Centinel Spine, LLC · Aug 2022
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K220861 · Spinal Kinetics, LLC · Jun 2022