Cleared Traditional

K222220 - SpinMedix Absorbable Fibrous Membrane (FDA 510(k) Clearance)

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

K222220 · Celestray Biotech Company, LLC., · Orthopedic device
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Jul 2023
Decision
346d
Days
Class 2
Risk

K222220 is an FDA 510(k) clearance for the SpinMedix Absorbable Fibrous Membrane. Classified as Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon (product code OWW), Class II - Special Controls.

Submitted by Celestray Biotech Company, LLC., (Bethesda, US). The FDA issued a Cleared decision on July 6, 2023 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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. Elevated predicate reliance 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 Celestray Biotech Company, LLC., devices

Submission Details

510(k) Number K222220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date July 06, 2023
Days to Decision 346 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
224d slower than avg
Panel avg: 122d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.
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 - OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

All 9
Devices cleared under the same product code (OWW) and FDA review panel - the closest regulatory comparables to K222220.
VersaCoat Tendon Protector (VTP-44G2)
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Rotium
K250021 · Nanofiber Solutions, LLC · Feb 2025
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K242187 · Conmed Corporation · Nov 2024
BioBrace® Reinforced Implant
K241906 · Conmed Corporation · Jul 2024
VersaWrap
K240817 · Alafair Biosciences, Inc. · Jun 2024
FlexBand
K230316 · International Life Sciences · May 2023