Cleared Traditional

K261882 - Pisces-SC Standalone Cervical Interbody System

K261882 is an FDA 510(k) clearance for Pisces-SC Standalone Cervical Interbody..., manufactured by Osseus Fusions Systems, LLC. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K261882 · Osseus Fusions Systems, LLC · Orthopedic device
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Aug 2026
Decision
77d
Days
Class 2
Risk

K261882 is an FDA 510(k) clearance for the Pisces-SC Standalone Cervical Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Osseus Fusions Systems, LLC (Dallas, US). The FDA issued a Cleared decision on August 21, 2026 after a review of 77 days - a notably fast clearance 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: 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 Osseus Fusions Systems, LLC devices

FDA 510(k) Submission Details - K261882

510(k) Number K261882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date August 21, 2026
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

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 Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K261882.
ZSAlign Cervical Interbody System
K261451 · Zsfab, Inc. · Jul 2026
E3D™-C Interbody System
K262094 · Evolution Spine · Jul 2026
DeltaNEC Interbody System
K261279 · Nexus Spine · Jun 2026
CONDUIT™ ZERO-P™ VA Secured Spacer System
K252982 · Avalign Technologies, Inc. · Jun 2026
NeckTune™ 3D SA Cervical Cage
K260036 · Medyssey Co, Ltd. · Jun 2026
SABER-C System
K260660 · Elevation Spine · Apr 2026