Delta Ceramic Femoral Head
The Ortho Development BIOLOX Delta Ceramic Femoral Head is the ball component of a total hip replacement. It mates with compatible Ovation or Encompass femoral stems through a 12/14 taper…
The Ortho Development BIOLOX Delta Ceramic Femoral Head is the ball component of a total hip replacement. It mates with compatible Ovation or Encompass femoral stems through a 12/14 taper and articulates against Ortho Development polyethylene acetabular liners.
The ceramic head family includes diameters of 28, 32, 36 and 40 mm with different offsets. These choices provide alternative head dimensions within the compatible hip system; the stem and acetabular liner are separate components.
Listed Item
Femoral Head 36-12/14+0
Compatible Hip Reconstruction
The Ovation stem is indicated for uncemented biological fixation, while the Encompass stem permits cemented or uncemented fixation. Total hip indications include arthritis, failed hip surgery, femoral neck or head fracture, avascular necrosis and structural abnormalities with sufficient bone to seat the prosthesis.
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Ortho Development Corp., United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111936 |
| Record published | 2016-08-16 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Sizes | Outer diameter 28 to 40 mm; length 3 to 9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 136-3600 | Outer Diameter 36 mm | In distribution |
| 136-4013 | Length 3 mm | In distribution |
| 136-3200 | Outer Diameter 32 mm | In distribution |
| 136-4000 | Outer Diameter 40 mm | In distribution |
| 136-3616 | Length 6 mm | In distribution |
| 136-2800 | Outer Diameter 28 mm | In distribution |
| 136-3630 | Outer Diameter 36 mm | In distribution |
| 136-4016 | Length 6 mm | In distribution |
| 136-2830 | Outer Diameter 28 mm | In distribution |
| 136-4030 | Outer Diameter 40 mm | In distribution |
| 136-3260 | Outer Diameter 32 mm | In distribution |
| 136-2813 | Outer Diameter 28 mm | In distribution |
| 136-3613 | Length 3 mm | In distribution |
| 136-3660 | Outer Diameter 36 mm | In distribution |
| 136-3230 | Outer Diameter 32 mm | In distribution |
| 136-4060 | Outer Diameter 40 mm | In distribution |
| 136-3213 | Length 3 mm | In distribution |
| 136-4019 | Length 9 mm | In distribution |
| 136-3216 | Outer Diameter 32 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111936 | 2011-09-21 |
| K060577 | 2006-04-28 |
| K053587 | 2006-03-17 |
| K970675 | 1997-08-22 |
| K971426 | 1997-07-09 |
| K971435 | 1997-07-09 |
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 |
|---|---|---|---|---|---|
| 2011-12-19 | Not classified | Device Design | Tip of hex-head screwdriver may break off during use in hip replacement procedure. | 37 units | 2012-08-27 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 7 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 33 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 7 units | 2011-11-04 |
| 2011-01-11 | Not classified | Process design | Component of total hip arthroplasty may break during surgical procedure. | 33 units | 2011-11-04 |
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.