Biorci Screw
FDA 510(k) K992396 · Smith & Nephew Endoscopy, Inc.
510(k) numberK992396
Submission
- Device name
- Biorci Screw
- Applicant
- Smith & Nephew Endoscopy, Inc.
Mansfield, MA, US - Received
- July 19, 1999
- Decision date
- January 12, 2000
- 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 |
|---|---|---|
| K103309 | Osteoraptor Curved 2.3 Suture AnchorsMAI · Traditional | 02/03/2011SE |
| K102660 | Bioraptor Curved 2.3 PK Suture AnchorsMBI · Traditional | 12/13/2010SE |
| K093428 | Smith & Nephew Knotless Instability AnchorMBI · Traditional | 12/17/2009SE |
| K083635 | Smith & Nephew Biosure PK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K083226 | Smith & Nephew PEEK Interference ScrewMBI · Traditional | 01/30/2009SE |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | 10/21/2008SE |
| K050580 | Smith & Nephew Intelijet Fluid Management SystemsHRX · Traditional | 04/20/2005SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | 07/14/1999SE |
| K972599 | Acufex Screw CannulaHWC · Traditional | 09/19/1997SE |
| K971939 | Smith & Nephew Suture ColletOCW · Traditional | 08/06/1997SE |
Questions and answers
When was Biorci Screw cleared by the FDA?
Biorci Screw (K992396) received a 510(k) decision of Substantially Equivalent on January 12, 2000, 177 days after the submission was received.
What is the product code of K992396?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.