WaveKahuna™
Femoral Component, Right, 11.5mm Offset, Kahuna, CE
7manufacturers in China registered for this device type
16catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Arthrosurface, Inc., United States |
|---|---|
| FDA product code | KRR |
| Device type | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3540 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K181280 |
| Record published | 2020-03-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PWR2-0705-A | In distribution | |
| PWL2-1005-W | In distribution | |
| PWL2-0705-W | In distribution | |
| PWL2-0855-W | In distribution | |
| PWR2-1155-W | In distribution | |
| PWR2-0855-A | In distribution | |
| PWL2-0855-A | In distribution | |
| PWR2-1005-W | In distribution | |
| PWL2-1155-W | In distribution | |
| PWR2-0705-W | In distribution | |
| PWR2-1155-A | In distribution | |
| PWR2-1005-A | In distribution | |
| PWR2-0855-W | In distribution | |
| PWL2-1005-A | In distribution | |
| PWL2-0705-A | In distribution | |
| PWL2-1155-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude Patello-Femoral System | Biomet Orthopedics | 61 |
| Prelude PF | Biomet Orthopedics | 59 |
| KneeTec PFJ | Corin Limited | 49 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Triathlon | Howmedica Osteonics Corp | 23 |
| Prelude PF | Biomet Sports Medicine | 21 |
| HemiCAPWAVE® | Arthrosurface, Inc. | 16 |
| Sigma | Depuy (Ireland) | 16 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181280 | 2018-06-14 |
| K071413 | 2007-11-09 |
| K060127 | 2006-03-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2022-12-22 | Class II | Device Design | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque. | 420 units |
| Medline Industries, LP – Northfield | 510(k) number | 2022-12-22 | Class II | Device Design | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque. | 420 units |
| Medline Industries, LP – Northfield | 510(k) number | 2022-12-22 | Class II | Device Design | The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque. | 190 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.