Rigidfix Soft Tissue Acl Crosspin System
FDA 510(k) K010633 · Mitek Products
510(k) numberK010633
Submission
- Device name
- Rigidfix Soft Tissue Acl Crosspin System
- Applicant
- Mitek Products
Norwood, MA, US - Received
- March 2, 2001
- Decision date
- May 9, 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 |
|---|---|---|
| K013572 | Mitek Biocryl Interference ScrewsHWC · Special | 03/14/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | 02/06/2002SE |
| K002639 | Bioknotless AnchorGAM · Traditional | 05/11/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | 02/15/2001SE |
| K003076 | Mitek CufftackMAI · Special | 10/27/2000SE |
| K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemGEI · Special | 08/31/2000SE |
| K002402 | Vapr TC Electrode for Use with Vapr II Electrosurgical SystemHRX · Special | 08/31/2000SE |
| K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemGEI · Special | 04/19/2000SE |
| K993575 | Resolve QuickanchorDZL · Traditional | 12/29/1999SE |
| K993327 | Talon Anchor Snap-PakDZL · Traditional | 12/16/1999SE |
Questions and answers
When was Rigidfix Soft Tissue Acl Crosspin System cleared by the FDA?
Rigidfix Soft Tissue Acl Crosspin System (K010633) received a 510(k) decision of Substantially Equivalent on May 9, 2001, 68 days after the submission was received.
What is the product code of K010633?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.