Healix Advance PEEK Anchor
FDA 510(k) K120449 · Depuy Mitek
510(k) numberK120449
Submission
- Device name
- Healix Advance PEEK Anchor
- Applicant
- Depuy Mitek
Raynham, MA, US - Received
- February 14, 2012
- Decision date
- May 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | 02/26/2026SE |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND AnchorMAI · Traditional | 02/05/2025SE |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAI · Special | 09/11/2024SE |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAI · Special | 03/15/2024SE |
| K233675 | FMS VUE Fluid Management and Tissue Debridement SystemHRX · Traditional | 02/26/2024SE |
| K143475 | VAPR Tripolar Suction ElectrodeGEI · Traditional | 04/03/2015SE |
| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…NEW · Special | 04/23/2008SE |
| K060664 | Fastin RC AnchorHWC · Traditional | 06/06/2006SE |
| K043298 | Blue Orthocord SutureNEW · Special | 12/10/2004SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | 05/28/2004SE |
Questions and answers
When was Healix Advance PEEK Anchor cleared by the FDA?
Healix Advance PEEK Anchor (K120449) received a 510(k) decision of Substantially Equivalent on May 11, 2012, 87 days after the submission was received.
What is the product code of K120449?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.