Knife, Orthopedic
FDA product code HTS · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
9510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | Associated Medical Products Co. | 02/22/1994SE |
| K933921 | Acuflex Disposable KnivesHTS · Traditional | Acufex Microsurgical, Inc. | 01/26/1994SE |
| K882525 | Spinal MicroknifeHTS · Traditional | Karlin Technology, Inc. | 09/22/1988SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873712 | Standard Knife, Disposable #TM-1610HTS · Traditional | Arthropedics, Inc. | 10/15/1987SE |
| K842820 | Arthroscopy KnivesHTS · Traditional | Medtech Industries, Inc. | 08/14/1984SE |
| K771851 | Arthroscope Operative Knife SetHTS · Traditional | Richard Wolf Medical Instruments Corp. | 10/27/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0197-2023 Class II | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used…Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to… | Beaver Visitec International, Inc. | 09/30/2022Open, Classified |
| Z-0529-2010 | Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel…Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33… | Stryker Howmedica Osteonics Corp. | 11/11/2009Terminated |
| Z-1638-2010 | BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company…Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left. | Becton Dickinson and Company | 06/12/2009Terminated |