Cleared Traditional

Tesera-k SC System (K242928) - FDA 510(k) Clearance

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

K242928 · Kyocera Medical Technologies, Inc. · Orthopedic device
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Apr 2025
Decision
198d
Days
Class 2
Risk

K242928 is an FDA 510(k) clearance for the Tesera-k SC System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on April 10, 2025 after a review of 198 days - an extended review cycle.

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 Kyocera Medical Technologies, Inc. devices

Submission Details

510(k) Number K242928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2024
Decision Date April 10, 2025
Days to Decision 198 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
76d slower than avg
Panel avg: 122d · This submission: 198d
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

Empirical Technologies
Nathan Wright

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 K242928.
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025
FIX-C PEEK ACIF SA System
K251431 · Jeil Medical Corporation · Jun 2025
Cervical Spine Truss System (CSTS)
K251117 · 4Web Medical · Apr 2025
CYLOX® ST
K243188 · Signus Medizintechnik GmbH · Feb 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · Genesys Spine · Feb 2025
ProAM ACDF System
K242517 · Pro Surgical, Inc. · Nov 2024