Biolox Delta
BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +1.5
4manufacturers in China registered for this device type
4catalogue numbers in this listing
12510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | KWA |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K073570 |
| Record published | 2015-03-24 |
| Record revised | 2026-05-13 (version 6) |
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 | 2022-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1365-28-710 | In distribution | |
| 1365-32-730 | In distribution | |
| 1365-44-710 | Withdrawn | |
| 1365-44-720 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 48 |
| Conserve® | Microport Orthopedics Inc. | 24 |
| RingLoc+ Hip System | Biomet Orthopedics | 21 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Zimmer, Inc. | 17 |
| Fitmore® Hip Stem | Zimmer, Inc. | 17 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Asphere | Depuy (Ireland) | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 9 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 7 |
| Kinectiv® | Zimmer, Inc. | 7 |
| M2A – Modular Head HIP System | Biomet Orthopedics | 6 |
| Transcend® | Microport Orthopedics Inc. | 5 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083642 | 2009-03-06 |
| K082585 | 2008-12-04 |
| K080991 | 2008-07-02 |
| K073413 | 2008-01-30 |
| K070359 | 2007-03-06 |
| K062426 | 2006-12-15 |
| K061221 | 2006-08-28 |
| K040627 | 2005-08-05 |
| K023786 | 2002-12-10 |
| K003523 | 2000-12-13 |
| K002883 | 2000-10-13 |
| K001523 | 2000-08-10 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-12-15 | Class II | Process control | Certain Pinnacle Cup devices may potentially exhibit an oversized “minor diameter”, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of “cross-threading”. If cross-th | 14161 lots (10 units/lot) | 2023-11-14 |
| 2014-06-03 | Class II | Device Design | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | 10,467 units | 2017-05-17 |
| 2014-06-03 | Class II | Device Design | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | 3,623 | 2017-05-17 |
| 2014-06-03 | Class II | Device Design | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | 814 units | 2017-05-17 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 8,374 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 60 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3385 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 286 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 2013-08-29 | |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 270 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 355 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 6419 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3578 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 2013-08-29 | |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 418 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 5241 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 5483 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 1,820 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 46 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 14,300 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 4,718 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 492 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 1708 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 271 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 43 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 73 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 258 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 484 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 80 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 1509 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3,273 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 2820 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 3 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 4,158 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 6011 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 4602 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 6,687 | 2013-08-29 |
| 2010-08-23 | Not classified | Device Design | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, intern | 1,550 | 2013-08-29 |
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.