Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle
FDA 510(k) K121306 · Arthocare Corporation
510(k) numberK121306
Submission
- Device name
- Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle
- Applicant
- Arthocare Corporation
Austin, TX, US - Received
- May 1, 2012
- Decision date
- July 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K153669 | MultiFIX S Ultra Knotless Fixation SystemMBI · Special | 01/19/2016SE |
| K131182 | Multifix S Knotless Fixation DeviceMBI · Traditional | 07/29/2013SE |
| K120791 | Ambient Turboflash 90 IfsGEI · Special | 12/11/2012SE |
| K123268 | Smartstitch Perfectpasser SystemGAT · Special | 11/07/2012SE |
| K013334 | EndoflipMBI · Traditional | 12/13/2001SE |
Questions and answers
When was Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle cleared by the FDA?
Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device Handle (K121306) received a 510(k) decision of Substantially Equivalent on July 12, 2012, 72 days after the submission was received.
What is the product code of K121306?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.