Cleared Traditional

SureMAX-SA Cervical Standalone System (K211111) - FDA 510(k) Clearance

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

K211111 · Additive Implants, Inc. · Orthopedic device
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Jul 2021
Decision
93d
Days
Class 2
Risk

K211111 is an FDA 510(k) clearance for the SureMAX-SA Cervical Standalone System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Additive Implants, Inc. (Phoenix, US). The FDA issued a Cleared decision on July 16, 2021 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Additive Implants, Inc. devices

Submission Details

510(k) Number K211111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2021
Decision Date July 16, 2021
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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

Backroads Consulting
Karen E Warden

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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K211111.
Idys-C ZP 3DTi
K212562 · Clariance, SA · Oct 2021
C-CURVE Interbody Fusion Device
K210470 · Medicrea International SA · Sep 2021
Blustone Synergy Diamond SA Cervical System
K210382 · Blustone Synergy, LLC · Jul 2021
ChoiceSpine Blackhawk Ti Cervical Spacer System
K203311 · Choice Spine, LLC · May 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · Precision Spine, Inc. · Jan 2021
IdentiTi Cervical Standalone Interbody System
K202812 · Alphatec Spine, Inc. · Dec 2020