Exactech
EXACTECH® CoCr FEM HEAD, 28mm O.D., +7, 12/14
13manufacturers in China registered for this device type
70catalogue numbers in this listing
12510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Exactech, Inc., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K963313 |
| Record published | 2015-08-10 |
| Record revised | 2020-04-06 (version 4) |
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 10 to 70 mm; lumen/inner diameter 22 to 32 mm |
| Distribution end date | 2021-01-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 106-22-58 | Outer Diameter 58 mm | In distribution |
| 100-22-08 | +8mm Offset | In distribution |
| 100-26-95 | -5mm Offset | In distribution |
| SK-029428 | G7,56/58/60MM CUP | In distribution |
| SK-029424 | G5,52MM CUP | In distribution |
| 106-22-62 | Outer Diameter 62 mm | In distribution |
| 100-36-00 | +0mm Offset | In distribution |
| SK-029429 | G8,62/64/66/68MM CUP | In distribution |
| 100-26-05 | +5mm Offset | In distribution |
| 106-22-60 | Outer Diameter 60 mm | In distribution |
| SK-029426 | G6,54MM CUP | In distribution |
| SK-029400 | G0,40MM CUP | In distribution |
| 100-36-05 | +5mm Offset | In distribution |
| 100-28-00 | +0mm Offset | In distribution |
| 106-22-70 | Outer Diameter 70 mm | In distribution |
| 100-28-95 | -5mm Offset | In distribution |
| 106-22-48 | Outer Diameter 48 mm | In distribution |
| SK-029411 | G2,46MM CUP | In distribution |
| 100-36-10 | +10mm Offset | In distribution |
| 142-36-10 | In distribution | |
| PC-17 | Outer Diameter 17 mm | In distribution |
| PC-16 | Outer Diameter 16 mm | In distribution |
| 100-28-05 | +5mm Offset | In distribution |
| 106-22-68 | Outer Diameter 68 mm | In distribution |
| SK-013517 | In distribution | |
| PC-11 | Outer Diameter 11 mm | In distribution |
| 100-26-00 | +0mm Offset | In distribution |
| PC-13 | Outer Diameter 13 mm | In distribution |
| 106-32-56 | Outer Diameter 56 mm | In distribution |
| SK-029409 | G1,42/44MM CUP | In distribution |
| 106-28-50 | Outer Diameter 50 mm | In distribution |
| SK-030350 | In distribution | |
| SK-029313 | In distribution | |
| PC-14 | Outer Diameter 14 mm | In distribution |
| 100-22-03 | Outer Diameter 22 mm | In distribution |
| 100-32-05 | +5mm Offset | In distribution |
| SK-029413 | G3,48MM CUP | In distribution |
| PC-12 | Outer Diameter 12 mm | In distribution |
| 100-26-10 | +10mm Offset | In distribution |
| 100-28-10 | +10mm Offset | In distribution |
| 106-22-56 | Outer Diameter 56 mm | In distribution |
| 142-28-07 | In distribution | |
| SK-029423 | G4,50MM CUP | In distribution |
| 100-32-00 | +0mm Offset | In distribution |
| 100-32-10 | +10mm Offset | In distribution |
| 100-22-02 | -2mm Offset | In distribution |
| PC-10 | Outer Diameter 10 mm | In distribution |
| 106-22-64 | Outer Diameter 64 mm | In distribution |
| 106-22-50 | Outer Diameter 50 mm | In distribution |
| 106-22-66 | Outer Diameter 66 mm | In distribution |
| PC-15 | Outer Diameter 15 mm | In distribution |
| SK-029368 | In distribution | |
| 100-36-95 | -5mm Offset | In distribution |
| SK-030125 | In distribution | |
| 100-32-95 | -5mm Offset | In distribution |
| 106-32-58 | Outer Diameter 58 mm | Withdrawn |
| 106-28-56 | Outer Diameter 56 mm | Withdrawn |
| 106-28-52 | Outer Diameter 52 mm | Withdrawn |
| 106-22-42 | Outer Diameter 42 mm | Withdrawn |
| 106-22-44 | Outer Diameter 44 mm | Withdrawn |
| 106-28-48 | Outer Diameter 48 mm | Withdrawn |
| 106-22-46 | Outer Diameter 45 mm | Withdrawn |
| 106-28-58 | Outer Diameter 58 mm | Withdrawn |
| 106-32-52 | Outer Diameter 52 mm | Withdrawn |
| 106-28-54 | Outer Diameter 54 mm | Withdrawn |
| 106-28-60 | Outer Diameter 60 mm | Withdrawn |
| 106-22-52 | Outer Diameter 52 mm | Withdrawn |
| 106-32-54 | Outer Diameter 54 mm | Withdrawn |
| 106-32-60 | Outer Diameter 60 mm | Withdrawn |
| 106-22-54 | Outer Diameter 54 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051335 | 2005-06-21 |
| K023646 | 2002-11-13 |
| K020291 | 2002-02-27 |
| K012493 | 2001-08-29 |
| K011218 | 2001-05-16 |
| K001335 | 2000-05-18 |
| K964262 | 1996-12-27 |
| K963313 | 1996-11-14 |
| K961304 | 1996-10-01 |
| K925201 | 1993-06-15 |
| K901297 | 1990-05-02 |
| K862234 | 1986-10-15 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|
| 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 | 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. | 4956 devices |
Recalls
2 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 |
|---|---|---|---|---|---|
| 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 | |
| 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. | 79 units | 2019-08-05 |
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.