Synthes (USA) Porous Polyethylene Implants
FDA 510(k) K051879 · Synthes (Usa)
510(k) numberK051879
Submission
- Device name
- Synthes (USA) Porous Polyethylene Implants
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- July 11, 2005
- Decision date
- October 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | Boston Scientific | 08/12/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | Aroa Biosurgery , Ltd. | 06/03/2025SE |
| K243595 | OviTex PRS (Long-Term Resorbable)FTM · Special | TELA Bio, Inc. | 12/19/2024SE |
| K233991 | CanGaroo RM Antibacterial EnvelopeFTM · Traditional | Elutia, Inc. | 06/14/2024SE |
| K241126 | OviTex PRSFTM · Special | TELA Bio, Inc. | 05/22/2024SE |
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | Synovis Life Technologies, Inc. | 04/07/2023SE |
| K214070 | OviTex PRS (Long Term Resorbable)FTM · Traditional | Tela Bio | 03/21/2023SE |
| K213163 | VersaWrapFTM · Special | Alafair Biosciences, Inc. | 10/29/2021SE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special | Synovis Life Technologies. Inc. (A Subsidiary of… | 10/27/2021SE |
| K203496 | Nexo-Gide Bilayer Collagen MembraneFTM · Traditional | Geistlich Pharma AG | 07/14/2021SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K180821 | TruMatch Graft Cage - Long BoneHRS · Traditional | 12/21/2018SE |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT · Traditional | 11/10/2016SE |
| K152239 | Zero-P Natural Plate SystemKWQ · Traditional | 12/02/2015SE |
| K141527 | Depuy Synthes Variable Angle Locking Hand SystemHRS · Traditional | 03/30/2015SE |
| K131984 | Synthes Synsonic Ulna NailHSB · Traditional | 03/31/2014SE |
| K130146 | Synthes Synflate Vertevral Balloon SystemNDN · Traditional | 05/20/2013SE |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateHRS · Traditional | 07/06/2012SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
| K120275 | Synthes Acis/Vertebral Spacer CRODP · Traditional | 05/25/2012SE |
Questions and answers
When was Synthes (USA) Porous Polyethylene Implants cleared by the FDA?
Synthes (USA) Porous Polyethylene Implants (K051879) received a 510(k) decision of Substantially Equivalent on October 5, 2005, 86 days after the submission was received.
What is the product code of K051879?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.