Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
FDA 510(k) K222978 · Xiros, Ltd.
510(k) numberK222978
Submission
- Device name
- Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
- Applicant
- Xiros, Ltd.
Leeds, GB - Received
- September 28, 2022
- Decision date
- December 27, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QUW – Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Other 510(k)s with product code QUW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262729 | TeKBrace Solo Soft Tissue Reinforcement DeviceQUW · Special | Theramicro | 08/18/2026SE |
| K261621 | TekBrace Solo Soft Tissue Reinforcement DeviceQUW · Special | Theramicro | 06/09/2026SE |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005)QUW · Traditional | Xiros Limited | 07/15/2025SE |
| K251063 | TekBrace Solo Soft Tissue Reinforcement DeviceQUW · Traditional | Theramicro | 05/30/2025SE |
More from Theramicro
| 510(k) | Device | Decision |
|---|---|---|
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005)QUW · Traditional | 07/15/2025SE |
| K230671 | Pitch PaSoft Tissue Reinforcement DeviceFTL · Traditional | 05/31/2023SE |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceFTL · Traditional | 08/26/2022SE |
| K220906 | Secure-LockHTY · Traditional | 07/22/2022SE |
| K211563 | Pitch-PatchsFTL · Traditional | 08/13/2021SE |
| K191053 | Xtreme-LoopMBI · Traditional | 07/17/2019SE |
| K180243 | Infinity-Lock Button SystemHTN · Traditional | 04/03/2018SE |
| K171680 | Infinity-Lock 3, Infinity-Lock 5GAT · Special | 06/30/2017SE |
| K151601 | Secure-LoopMBI · Traditional | 09/09/2015SE |
| K002172 | Poly-Tapes (Various Sizes and Woven Construction Variants)GAT · Traditional | 08/28/2001SE |
Questions and answers
When was Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device cleared by the FDA?
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978) received a 510(k) decision of Substantially Equivalent on December 27, 2022, 90 days after the submission was received.
What is the product code of K222978?
The FDA product code is QUW – Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament, a Class II (moderate risk) device regulated under 21 CFR 878.3300.