Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
PILOT SHAFT, MILL GUIDE, METAPHYSEAL, 21mm x 165mm
14manufacturers in China registered for this device type
52catalogue numbers in this listing
19510(k) clearances naming this product code
26recalls 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 | Exactech, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K010120 |
| Record published | 2022-08-25 |
| Record revised | 2025-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 3.2 to 32 mm; length 20 to 165 mm; depth 8 to 13 mm; lumen/inner diameter 4.5 mm; width 11 mm |
| Distribution end date | 2025-08-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 163-02-07 | SIZE 7 | In distribution |
| 189-02-02 | SIZE 2 | In distribution |
| 01-007-05-0045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 189-12-09 | SIZE 9 | In distribution |
| 189-02-01 | SIZE 1 | In distribution |
| 113-03-21 | In distribution | |
| 101-05-07 | EXTRA LONG | In distribution |
| 01-003-04-0004 | In distribution | |
| 121-01-00 | In distribution | |
| 140-32-93 | Outer Diameter 32 mm | In distribution |
| 140-32-03 | +3.5mm Offset | In distribution |
| 101-05-12 | In distribution | |
| 113-01-06 | SIZE 6 | In distribution |
| 101-13-03 | Medium | In distribution |
| 163-02-05 | SIZE 5 | In distribution |
| 101-05-46 | In distribution | |
| 189-12-01 | SIZE 1 | In distribution |
| 101-05-02 | Long | In distribution |
| 163-02-03 | SIZE 3 | In distribution |
| 141-01-22 | Outer Diameter 22 mm | In distribution |
| 181-00-12 | GROUP 2 | In distribution |
| 131-01-28 | Outer Diameter 28 mm | In distribution |
| 101-45-20 | Drill Diameter | In distribution |
| 140-28-00 | +0mm Offset | In distribution |
| 113-01-02 | SIZE 2 | In distribution |
| 01-003-02-0006 | In distribution | |
| 151-10-10 | STRAIGHT | Withdrawn |
| 187-00-02 | Withdrawn | |
| 151-10-22 | STRAIGHT | Withdrawn |
| 151-14-21 | Pilot Length | Withdrawn |
| 151-10-20 | Outer Diameter 21 mm | Withdrawn |
| 140-28-93 | -3.5mm Offset | Withdrawn |
| 151-14-12 | Length 165 mm | Withdrawn |
| 187-04-13 | LARGE | Withdrawn |
| 151-14-19 | Pilot Length | Withdrawn |
| 151-50-21 | Outer Diameter 21 mm | Withdrawn |
| 151-10-04 | STRAIGHT | Withdrawn |
| 140-28-03 | Outer Diameter 28 mm | Withdrawn |
| 187-05-13 | LARGE | Withdrawn |
| 151-50-29 | Outer Diameter 29 mm | Withdrawn |
| 187-01-11 | GROUP 1 | Withdrawn |
| 151-50-02 | Withdrawn | |
| 153-23-00 | 23mm | Withdrawn |
| 151-10-27 | Outer Diameter 21.5 mm | Withdrawn |
| 187-03-13 | Depth 13 mm | Withdrawn |
| 187-03-08 | GROUP 3 | Withdrawn |
| 151-50-31 | Outer Diameter 31 mm | Withdrawn |
| 151-10-11 | Outer Diameter 15 mm | Withdrawn |
| 151-14-10 | Length 165 mm | Withdrawn |
| 140-32-00 | Outer Diameter 32 mm | Withdrawn |
| 151-50-03 | Withdrawn | |
| 187-02-11 | Depth 11 mm | 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 |
|---|---|
| K182502 | 2019-03-13 |
| K141960 | 2015-09-03 |
| K141797 | 2014-07-29 |
| K122798 | 2012-10-11 |
| K121684 | 2012-10-01 |
| K113609 | 2012-01-04 |
| K102975 | 2010-11-05 |
| K101761 | 2010-09-21 |
| K100269 | 2010-05-27 |
| K051556 | 2005-09-06 |
| K041906 | 2004-09-10 |
| K032964 | 2003-11-13 |
| K030236 | 2003-02-20 |
| K011081 | 2001-04-24 |
| K010120 | 2001-02-09 |
| K993736 | 2000-01-20 |
| K993082 | 1999-11-19 |
| K921113 | 1993-10-27 |
| K921114 | 1993-10-27 |
Recalls Naming This Product
37 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 | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 42 | |
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 87 | |
| Exactech, Inc. | 510(k) number | 2024-12-31 | Class II | Nonconforming Material/Component | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | 1446 | |
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2023-11-21 | Class II | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | ||
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 132 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 58158 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 2319 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 3793 devices | |
| Exactech, Inc. | 510(k) number | 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 7946 devices | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 29 devices | |
| Exactech, Inc. | 510(k) number | 2021-06-29 | Class II | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | 30 devices | |
| Exactech, Inc. | 510(k) number | 2017-10-09 | Class II | Error in labeling | Wrong device description of the label identifying the implant | 34 | 2019-08-06 |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 12 devices | 2019-08-05 |
| Exactech, Inc. | 510(k) number | 2016-11-07 | Class II | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | 98 | 2019-08-05 |
| Exactech, Inc. | 510(k) number | 2013-09-11 | Class II | Employee error | Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. | 235 | 2014-08-04 |
| Exactech, Inc. | 510(k) number | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
| Exactech, Inc. | 510(k) number | 2012-11-05 | Class II | Labeling mix-ups | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed | 26 Units | 2013-12-24 |
| Exactech, Inc. | 510(k) number | 2007-11-01 | Not classified | Process control | Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 – 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm | 10 | 2012-05-06 |
| Exactech, Inc. | 510(k) number | 2006-07-21 | Not classified | Other | The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device. | 6 | 2012-05-06 |
Recalls
6 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 |
|---|---|---|---|---|
| 2022-08-11 | Class II | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | 11143 DEVICES |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total |
| 2021-06-29 | Class II | Unknown/Undetermined by firm | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | 89,050 total |
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.