Tapestry Biointegrative Implant
FDA 510(k) K220867 · Embody, Inc.
510(k) numberK220867
Submission
- Device name
- Tapestry Biointegrative Implant
- Applicant
- Embody, Inc.
Norfolk, VA, US - Received
- March 25, 2022
- Decision date
- May 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in tendon repair.
Other 510(k)s with product code OWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251690 | Arthrex SpeedFLEX ImplantOWY · Traditional | Arthrex, Inc. | 09/30/2025SE |
| K252647 | Tapestry Biointegrative ImplantOWY · Special | Embody, Inc. | 09/19/2025SE |
| K250109 | TYBR Collagen GelOWY · Traditional | Tybr Health | 06/06/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | Kerecis Limited | 06/04/2025SE |
| K242631 | REGENETEN Bioinductive ImplantOWY · Traditional | Smith & Nephew Inc., Endoscopy Div. | 11/26/2024SE |
| K222501 | Regeneten Bioinductive ImplantOWY · Traditional | Smith and Nephew, Inc. | 05/11/2023SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 11/02/2021SE |
| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | Embody, Inc. | 10/19/2020SE |
| K151083 | BioBridge Collagen MatrixOWY · Traditional | Fibralign Corporation | 01/08/2016SE |
| K140300 | Collagen Tendon Sheet-Ddi (Cts-Ddi)OWY · Traditional | Rotation Medical, Inc. | 03/26/2014SE |
More from Rotation Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252647 | Tapestry Biointegrative ImplantOWY · Special | 09/19/2025SE |
| K223822 | ActivbraidGAT · Traditional | 06/02/2023SE |
| K213958 | Bioabsorbable AnchorMAI · Traditional | 04/08/2022SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | 11/02/2021SE |
| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | 10/19/2020SE |
Questions and answers
When was Tapestry Biointegrative Implant cleared by the FDA?
Tapestry Biointegrative Implant (K220867) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 59 days after the submission was received.
What is the product code of K220867?
The FDA product code is OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.