Hi-Fi Ultrafix Knotless Minimite Suture Anchor
FDA 510(k) K060714 · Conmed Linvatec
510(k) numberK060714
Submission
- Device name
- Hi-Fi Ultrafix Knotless Minimite Suture Anchor
- Applicant
- Conmed Linvatec
Largo, FL, US - Received
- March 17, 2006
- Decision date
- April 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111779 | Y-Knot All-Suture Anchor Model HF13MBI · Traditional | 08/08/2011SE |
| K102410 | Matryx Interference Screw (5.0-6.5MM)HWC · Traditional | 12/21/2010SE |
| K102339 | Conmed Linvatec Sequent Meniscal Repair DeviceGAT · Traditional | 11/23/2010SE |
| K101100 | Crossft Oc Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503MAI · Traditional | 08/26/2010SE |
| K092898 | Conmed Linvatec Presto Preloaded with One or Two #2 Hi-Fi SuturesMAI · Special | 10/19/2009SE |
| K090560 | Conmed Linvatec Anodized Aluminum Sterilization TraysKCT · Abbreviated | 06/29/2009SE |
| K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)HRX · Traditional | 03/27/2009SE |
| K080531 | Conmed Linvatec Microfracture Instrument Sterilization TrayKCT · Traditional | 09/05/2008SE |
| K072291 | Conmed Linvatec Bio Mini-Revo Suture AnchorHWC · Traditional | 07/14/2008SE |
| K080444 | Conmed Linvatec Osprey Drill SystemHBC · Traditional | 04/02/2008SE |
Questions and answers
When was Hi-Fi Ultrafix Knotless Minimite Suture Anchor cleared by the FDA?
Hi-Fi Ultrafix Knotless Minimite Suture Anchor (K060714) received a 510(k) decision of Substantially Equivalent on April 6, 2006, 20 days after the submission was received.
What is the product code of K060714?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.