Cleared Traditional

Reef TO/TA System (K240830) - FDA 510(k) Clearance

Also marketed or referenced as:
Regatta Lateral System Explorer TO System WaveForm C Interbody System WaveForm TO Interbody System WaveForm TA Interbody System FORZA XP Expandable Spacer System Shoreline ACS Interbody System Shoreline RT Interbody System Meridian Interbody System WaveForm A Interbody System

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

K240830 · Orthofix Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
86d
Days
Class 2
Risk

K240830 is an FDA 510(k) clearance for the Reef TO/TA System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Orthofix Medical, Inc. (Lewisville, US). The FDA issued a Cleared decision on June 20, 2024 after a review of 86 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 Orthofix Medical, Inc. devices

Submission Details

510(k) Number K240830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2024
Decision Date June 20, 2024
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K240830.
sagAlign Lumbar Cage System (Various PNs)
K241413 · Acuity Surgical Devices, LLC · Jul 2024
SPIRA® Anterior Lumbar Spacers
K234077 · Camber Spine Technologies · Jul 2024
aprevo® TLIF-C Articulating System
K241019 · Carlsmed · Jul 2024
Shoreline ACS Interbody System
K241466 · SeaSpine Orthopedics Corporation · Jun 2024
PILLAR SA Ti Spacer System (82-XXX)
K240749 · Orthofix, Inc. · May 2024
Reef L Interbody System
K240566 · SeaSpine Orthopedics Corporation · Apr 2024