SMF, Stiktite
SMF Stem With Stiktite SZ 1
14manufacturers in China registered for this device type
9catalogue numbers in this listing
32510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| 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 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K080625 |
| Record published | 2015-08-30 |
| Record revised | 2023-09-07 (version 4) |
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 | 2018-01-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71352501 | Withdrawn | |
| 71352507 | Withdrawn | |
| 71352508 | Withdrawn | |
| 71352502 | Withdrawn | |
| 71352505 | Withdrawn | |
| 71352503 | Withdrawn | |
| 71352506 | Withdrawn | |
| 71352504 | Withdrawn | |
| 71352509 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242375 | 2024-10-07 |
| K232667 | 2023-10-27 |
| K220959 | 2022-08-18 |
| K211176 | 2022-07-01 |
| K211330 | 2022-01-19 |
| K191002 | 2019-10-31 |
| K190847 | 2019-10-25 |
| K182109 | 2018-11-16 |
| K181366 | 2018-09-24 |
| K171934 | 2017-11-30 |
| K171073 | 2017-11-21 |
| K172684 | 2017-10-03 |
| K150790 | 2015-11-16 |
| K123012 | 2012-10-24 |
| K122244 | 2012-08-23 |
| K110135 | 2011-10-14 |
| K103256 | 2011-01-31 |
| K092098 | 2010-01-22 |
| K081566 | 2008-08-21 |
| K072817 | 2008-05-15 |
| K080625 | 2008-05-08 |
| K072417 | 2008-01-10 |
| K071160 | 2007-10-05 |
| K060630 | 2006-06-14 |
| K022902 | 2002-10-02 |
| K022556 | 2002-08-28 |
| K012787 | 2002-03-15 |
| K013658 | 2001-12-05 |
| K002747 | 2000-12-15 |
| K991026 | 1999-10-22 |
| K991485 | 1999-07-12 |
| K983834 | 1999-02-24 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2019-02-19 | Class II | Packaging process control | Complaints were received indicating that the outer label incorrectly identified the product as size “1” instead of “-1”. The product contained within the package is size “-1” | 58 units | 2021-05-21 |
| 2019-02-19 | Class II | Packaging process control | Complaints were received indicating that the outer label incorrectly identified the product as size “1” instead of “-1”. The product contained within the package is size “-1” | 9 units | 2021-05-21 |
| 2013-11-25 | Class II | Other | One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell. | 38 units | 2017-02-01 |
| 2008-11-21 | Not classified | Process control | Liners measuring 28 mm ID and were mismarked as 32 mm. | 19 units | 2011-11-21 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.