STR Graft

FDA 510(k) K121216 · Soft Tissue Regeneration, Inc.

Substantially Equivalent

510(k) numberK121216

Submission

Device name
STR Graft
Applicant
Soft Tissue Regeneration, Inc.
Vero Beach, FL, US
Received
April 23, 2012
Decision date
November 21, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWW – Mesh, Surgical, Absorbable, 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 during tendon repair procedures.

Other 510(k)s with product code OWW

510(k)DeviceApplicantDecision
K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)OWW · Traditional Alafair Biosciences07/18/2025SE
K250021RotiumOWW · Traditional Nanofiber Solutions, LLC02/27/2025SE
K242187BioBrace®OWW · Traditional Conmed Corporation11/27/2024SE
K241906BioBrace® Reinforced ImplantOWW · Special Conmed Corporation07/29/2024SE
K240817VersaWrapOWW · Traditional Alafair Biosciences, Inc.06/14/2024SE
K222220SpinMedix Absorbable Fibrous MembraneOWW · Traditional Celestray Biotech Company, LLC.,07/06/2023SE
K230316FlexBand; FlexPatch; FlexBand PlusOWW · Traditional International Life Sciences05/26/2023SE
K203267The BioBrace ImplantOWW · Traditional Biorez, Inc.04/30/2021SE
K160364VersaWrap Tendon ProtectorOWW · Traditional Alafair Biosciences, Inc.06/10/2016SE

Questions and answers

When was STR Graft cleared by the FDA?

STR Graft (K121216) received a 510(k) decision of Substantially Equivalent on November 21, 2012, 212 days after the submission was received.

What is the product code of K121216?

The FDA product code is OWW – Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.