Cleared Traditional

K250554 - prodisc® L Instruments (FDA 510(k) Clearance)

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

K250554 · Centinel Spine, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
59d
Days
Class 2
Risk

K250554 is an FDA 510(k) clearance for the prodisc® L Instruments. Classified as Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ), Class II - Special Controls.

Submitted by Centinel Spine, LLC (West Chester, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 59 days - a notably fast clearance 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: 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 Centinel Spine, LLC devices

Submission Details

510(k) Number K250554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2025
Decision Date April 25, 2025
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 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 K250554.
Synergy Disc Instruments
K253392 · Synergy Spine Solutions, Inc. · Mar 2026
prodisc® L Instruments
K242869 · Centinel Spine, LLC · Dec 2024
M6-C™ Single Use, Disposable Instrumentation
K241117 · Spinal Kinetics / Orthofix / Seaspine · Jun 2024
activL® Next Generation Instrumentation
K231769 · Aesculap Implants Systems, LLC · Jul 2023
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848 · Centinel Spine, LLC · Aug 2022
M6-C Artificial Cervical Disc Instruments AS
K220861 · Spinal Kinetics, LLC · Jun 2022