Cleared Traditional

K262721 - Spinalogic Bone Growth Stimulator

K262721 is an FDA 510(k) clearance for Spinalogic Bone Growth Stimulator, manufactured by Djo, LLC. The device is a Class 3 Orthopedic device with product code LOF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262721 · Djo, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
60d
Days
Class 3
Risk

K262721 is an FDA 510(k) clearance for the Spinalogic Bone Growth Stimulator. Classified as Stimulator, Bone Growth, Non-invasive (product code LOF), Class III - Premarket Approval.

Submitted by Djo, LLC (Carlsbad, US). The FDA issued a Cleared decision on September 29, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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 Djo, LLC devices

FDA 510(k) Submission Details - K262721

510(k) Number K262721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2026
Decision Date September 29, 2026
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

LOF Device Classification - Class 3, Premarket Approval

Product Code LOF Stimulator, Bone Growth, Non-invasive
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Consultant

Hogan Lovells Cadwalader US LLP
Kristin Duggan

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.

Clinical Evidence

ClinicalTrials.gov
NCT05101057 Unknown Observational Industry-sponsored

A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients

A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients

400
Patients (est.)
2
Sites
Condition studied Degeneration of Cervical Intervertebral Disc
Eligibility All sexes · 18 Years+
Principal investigator Ruba Sarris, MPH
Sponsor Encore Medical, L.P. (industry)
Started 2021-11-15 → Primary completion 2022-03-01 → Completed 2022-06-01
Primary outcome
Time to fusion
Secondary outcome
Patient Reported Outcome Measures VAS
View full study on ClinicalTrials.gov