Cleared Traditional

TAPESTRY Biointegrative Implant (K201572) - FDA 510(k) Clearance

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

K201572 · Embody, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
130d
Days
Class 2
Risk

K201572 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 October 19, 2020 after a review of 130 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 K201572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2020
Decision Date October 19, 2020
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 Consultant

Bruder Consulting and Venture Group
Scott Bruder

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 - OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

All 9
Devices cleared under the same product code (OWY) and FDA review panel - the closest regulatory comparables to K201572.
Regeneten Bioinductive Implant
K222501 · Smith and Nephew, Inc. · May 2023
Tapestry Biointegrative Implant
K220867 · Embody, Inc. · May 2022
Tapestry Biointegrative Implant
K212306 · Embody, Inc. · Nov 2021
TRELLIS COLLAGEN RIBBON
K131143 · Wrightmedicaltechnologyinc · Oct 2013