Resorbable Screw Anchor
FDA 510(k) K012872 · Arthrotek, Inc.
510(k) numberK012872
Submission
- Device name
- Resorbable Screw Anchor
- Applicant
- Arthrotek, Inc.
Warsaw, IN, US - Received
- August 27, 2001
- Decision date
- November 20, 2001
- 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 |
|---|---|---|
| K061776 | Arthrotek Maxfire Meniscal Repair DeviceJDR · Traditional | 09/25/2006SE |
| K061801 | 2.8 & 3.5MM Lactoscrew Suture AnchorsJDR · Traditional | 08/07/2006SE |
| K061657 | Hitch Lactosorb Suture AnchorJDR · Traditional | 07/25/2006SE |
| K061389 | Allthread Lactosorb Suture AnchorJDR · Traditional | 07/19/2006SE |
| K060693 | Microstrike and Allthread PEEK Suture AnchorHWC · Traditional | 06/06/2006SE |
| K053461 | Ezloc Femoral Fixation DeviceMBI · Traditional | 02/03/2006SE |
| K051069 | Nonresorbable Centraloc Tibial Screw & WasherMBI · Traditional | 06/29/2005SE |
| K042460 | Ti - Screw Anchor SPMBI · Traditional | 10/29/2004SE |
| K041274 | Resorbable Interference ScrewHWC · Traditional | 07/28/2004SE |
| K041261 | Femoral HookMBI · Special | 06/07/2004SE |
Questions and answers
When was Resorbable Screw Anchor cleared by the FDA?
Resorbable Screw Anchor (K012872) received a 510(k) decision of Substantially Equivalent on November 20, 2001, 85 days after the submission was received.
What is the product code of K012872?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.