Cleared Traditional

K212306 - Tapestry Biointegrative Implant (FDA 510(k) Clearance)

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

K212306 · Embody, Inc. · Orthopedic device
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Nov 2021
Decision
102d
Days
Class 2
Risk

K212306 is an FDA 510(k) clearance for the Tapestry Biointegrative Implant. Classified as Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon (product code OWY), Class II - Special Controls.

Submitted by Embody, Inc. (Norfolk, US). The FDA issued a Cleared decision on November 2, 2021 after a review of 102 days - within the typical 510(k) review window.

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. 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 Embody, Inc. devices

Submission Details

510(k) Number K212306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2021
Decision Date November 02, 2021
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWY Mesh, Surgical, Collagen, 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 In Tendon Repair.
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 - OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

All 13
Devices cleared under the same product code (OWY) and FDA review panel - the closest regulatory comparables to K212306.
Arthrex SpeedFLEX™ Implant
K251690 · Arthrex, Inc. · Sep 2025
Tapestry Biointegrative Implant
K252647 · Embody, Inc. · Sep 2025
TYBR Collagen Gel
K250109 · Tybr Health · Jun 2025
Tendon Protect (50242)
K243843 · Kerecis Limited · Jun 2025
REGENETEN™ Bioinductive Implant
K242631 · Smith & Nephew Inc., Endoscopy Div. · Nov 2024
Regeneten Bioinductive Implant
K222501 · Smith and Nephew, Inc. · May 2023