Allofix Anchor
FDA 510(k) K053339 · Musculoskeletal Transplant Foundation
510(k) numberK053339
Submission
- Device name
- Allofix Anchor
- Applicant
- Musculoskeletal Transplant Foundation
Edison, NJ, US - Received
- December 1, 2005
- Decision date
- March 16, 2006
- 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 |
|---|---|---|
| K181633 | MTF Pre-Sutured TendonGAT · Traditional | 03/15/2019SE |
| K121313 | MTF New Bone Void FillerMQV · Traditional | 01/11/2013SE |
| K120479 | MTF FasciaOWY · Traditional | 11/08/2012SE |
| K113167 | MTF New Bone Voild FillerMQV · Traditional | 01/24/2012SE |
| K110003 | MTF New Bone Void FillerMQV · Traditional | 10/13/2011SE |
| K103795 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K103784 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K091217 | DBX Demineralized Bone Matrix PuttyNUN · Traditional | 10/02/2009SE |
| K091218 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 09/28/2009SE |
| K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMBP · Traditional | 10/10/2008SE |
Questions and answers
When was Allofix Anchor cleared by the FDA?
Allofix Anchor (K053339) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 105 days after the submission was received.
What is the product code of K053339?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.