Biolox® Forte
Biolox Prosthesis Head 12/14 32MM L
9manufacturers in China registered for this device type
6catalogue numbers in this listing
2510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | LWJ |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2021-10-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2016-03-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NK562 | Neck length : + 4.0 | Withdrawn |
| NK460 | Outer diameter (mm) : 28.000 MM | Withdrawn |
| NK462 | Figure / Size : Size L | Withdrawn |
| NK461 | Neck length : 0 | Withdrawn |
| NK561 | Outer diameter (mm) : 32.000 MM | Withdrawn |
| NK560 | Outer diameter (mm) : 32.000 MM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Iconacy i-Hip | Iconacy Orthopedic Implants, LLC | 154 |
| ZMR® | Zimmer, Inc. | 129 |
| Instrument | Howmedica Osteonics Corp | 120 |
| Restoration | Howmedica Osteonics Corp | 66 |
| U2 Hip Stem | United Orthopedic Corp. | 60 |
| Trinity Acetabular Hip System | Corin Limited | 58 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Exactech, Inc. | 51 |
| Omnifit | Howmedica Osteonics Corp | 48 |
| Novation | Exactech, Inc. | 48 |
| Endo-Model SL Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 46 |
| Trident | Howmedica Osteonics Corp | 43 |
| Kinectiv® | Zimmer, Inc. | 41 |
Showing 12 of 131. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061699 | 2006-08-18 |
| K042344 | 2005-03-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
| 2007-10-10 | Not classified | Package design/selection | Sterility (package integrity) Compromised: Device package damaged during shipment | 167 units | 2008-02-07 |
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.