Cleared Traditional

K211757 - Simplify Disc (FDA 510(k) Clearance)

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

K211757 · Nuvasive, Inc. · Orthopedic device
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Aug 2021
Decision
74d
Days
Class 2
Risk

K211757 is an FDA 510(k) clearance for the Simplify Disc. Classified as Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ), Class II - Special Controls.

Submitted by Nuvasive, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 20, 2021 after a review of 74 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K211757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2021
Decision Date August 20, 2021
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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
Justin Eggleton

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 K211757.
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