Cleared Special

K231769 - activL® Next Generation Instrumentation (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231769 · Aesculap Implants Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
27d
Days
Class 2
Risk

K231769 is an FDA 510(k) clearance for the activL® Next Generation Instrumentation. Classified as Manual Instruments Designed For Use With Total Disc Replacement Devices (product code QLQ), Class II - Special Controls.

Submitted by Aesculap Implants Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on July 13, 2023 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap Implants Systems, LLC devices

Submission Details

510(k) Number K231769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date July 13, 2023
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K231769.
Synergy Disc Instruments
K253392 · Synergy Spine Solutions, Inc. · Mar 2026
prodisc® L Instruments
K250554 · Centinel Spine, LLC · Apr 2025
prodisc® L Instruments
K242869 · Centinel Spine, LLC · Dec 2024
M6-C™ Single Use, Disposable Instrumentation
K241117 · Spinal Kinetics / Orthofix / Seaspine · Jun 2024
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