Apex
Disposable end caps (White) Apex Dia 4mm
9manufacturers in China registered for this device type
176catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K061493 |
| Record published | 2015-09-24 |
| Record revised | 2026-02-09 (version 8) |
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 |
| Sizes | Length 33 to 300 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5009-6-200S | Length 200.0 mm | In distribution |
| 5009-8-200S | Length 200.0 mm | In distribution |
| 5038-1-080S | In distribution | |
| 5027-4-180 | Diameter: 4.0 Millimeter | In distribution |
| 5015-3-120 | Diameter: 5.0 Millimeter | In distribution |
| 5021-6-180 | Length 180.0 mm | In distribution |
| 5014-9-250S | Diameter: 6.0 Millimeter | In distribution |
| 5009-7-250S | Length 250.0 mm | In distribution |
| 5020-7-250 | Diameter: 5.0 Millimeter | In distribution |
| 5009-2-200S | Diameter: 5.0 Millimeter | In distribution |
| 5009-9-250S | Length 250.0 mm | In distribution |
| 5014-5-200S | Diameter: 6.0 Millimeter | In distribution |
| 5017-5-150S | Diameter: 5.0 Millimeter | In distribution |
| 5009-8-250S | Length 250.0 mm | In distribution |
| 5027-3-120 | Length 120.0 mm | In distribution |
| 5070-7-820 | Length 78.0 mm | In distribution |
| 5013-3-120S | Length 120.0 mm | In distribution |
| 5038-5-060 | Length 60.0 mm | In distribution |
| 5023-5-150S | Diameter: 4.0 Millimeter | In distribution |
| 5017-5-180S | Length 180.0 mm | In distribution |
| 5065-5-020 | Diameter: 2.0 Millimeter | In distribution |
| 5030-3-200 | Diameter: 5.0 Millimeter | In distribution |
| 5070-3-810 | Diameter: 1.5 Millimeter | In distribution |
| 5014-6-200S | Diameter: 6.0 Millimeter | In distribution |
| 5065-3-918 | Length 39.0 mm | In distribution |
| 5008-8-150S | Diameter: 4.0 Millimeter | In distribution |
| 5015-6-180 | Length 180.0 mm | In distribution |
| 5020-3-150 | Length 150.0 mm | In distribution |
| 5021-8-200 | Length 200.0 mm | In distribution |
| 5030-5-250 | Diameter: 4.0 Millimeter | In distribution |
| 5038-5-080S | Diameter: 3.0 Millimeter | In distribution |
| 5018-6-180 | Diameter: 5.0 Millimeter | In distribution |
| 5030-5-300 | Diameter: 5.0 Millimeter | In distribution |
| 5030-6-250 | Diameter: 5.0 Millimeter | In distribution |
| 5038-5-060S | Diameter: 3.0 Millimeter | In distribution |
| 5018-5-250 | Diameter: 5.0 Millimeter | In distribution |
| 5018-5-150S | Length 150.0 mm | In distribution |
| 5014-5-150S | Diameter: 6.0 Millimeter | In distribution |
| 5023-3-090 | Diameter: 4.0 Millimeter | In distribution |
| 5019-8-250 | Diameter: 6.0 Millimeter | In distribution |
| 5017-8-150S | Length 150.0 mm | In distribution |
| 5010-8-250S | Length 250.0 mm | In distribution |
| 5030-4-300 | Length 300.0 mm | In distribution |
| 5038-1-110 | Diameter: 3.0 Millimeter | In distribution |
| 5027-5-180 | Length 180.0 mm | In distribution |
| 5014-3-200S | Length 200.0 mm | In distribution |
| 5009-9-200S | Length 200.0 mm | In distribution |
| 5030-5-250S | Length 250.0 mm | In distribution |
| 5030-3-250 | Diameter: 5.0 Millimeter | In distribution |
| 5017-3-150S | Diameter: 5.0 Millimeter | In distribution |
| 5014-7-250S | Diameter: 6.0 Millimeter | In distribution |
| 5030-7-300 | Diameter: 4.0 Millimeter | In distribution |
| 5010-8-200S | Length 200.0 mm | In distribution |
| 5015-5-150 | Length 150.0 mm | In distribution |
| 5036-1-080 | Diameter: 3.0 Millimeter | In distribution |
| 5030-4-250S | Diameter: 4.0 Millimeter | In distribution |
| 5014-4-180S | Diameter: 6.0 Millimeter | In distribution |
| 5070-6-315 | Diameter: 2.0 Millimeter | In distribution |
| 5013-2-150S | Diameter: 4.0 Millimeter | In distribution |
| 5050-5-300 | Diameter: 5.0 Millimeter | In distribution |
| 5018-7-250 | Diameter: 5.0 Millimeter | In distribution |
| 5014-5-180S | Length 180.0 mm | In distribution |
| 5014-2-120S | Length 120.0 mm | In distribution |
| 5019-7-150 | Length 150.0 mm | In distribution |
| 5020-6-120 | Diameter: 5.0 Millimeter | In distribution |
| 5016-5-111 | Diameter: 5.0 Millimeter | In distribution |
| 5038-2-080 | Diameter: 3.0 Millimeter | In distribution |
| 5018-6-180S | Length 180.0 mm | In distribution |
| 5027-1-050 | Diameter: 5.0 Millimeter | In distribution |
| 5013-8-150S | Length 150.0 mm | In distribution |
| 5017-2-150S | Diameter: 5.0 Millimeter | In distribution |
| 5010-6-200S | Diameter: 6.0 Millimeter | In distribution |
| 5036-2-060 | Length 60.0 mm | In distribution |
| 5016-5-117 | Diameter: 5.0 Millimeter | In distribution |
| 5090-2-120 | Diameter: 4.0 Millimeter | In distribution |
| 5065-4-520 | Diameter: 2.0 Millimeter | In distribution |
| 5014-6-150S | Length 150.0 mm | In distribution |
| 5017-7-200S | Length 200.0 mm | In distribution |
| 5014-4-150S | Diameter: 6.0 Millimeter | In distribution |
| 5065-9-015 | Length 90.0 mm | In distribution |
| 5065-3-615 | Length 36.0 mm | In distribution |
| 5014-8-250S | Diameter: 6.0 Millimeter | In distribution |
| 5010-4-200S | Diameter: 6.0 Millimeter | In distribution |
| 5027-4-150 | Diameter: 4.0 Millimeter | In distribution |
| 5018-5-200 | Length 200.0 mm | In distribution |
| 5030-5-200 | Length 200.0 mm | In distribution |
| 5023-5-150 | Length 150.0 mm | In distribution |
| 5038-2-110S | Length 110.0 mm | In distribution |
| 5010-3-200S | Length 200.0 mm | In distribution |
| 5020-8-180 | Diameter: 5.0 Millimeter | In distribution |
| 5018-8-180 | Length 180.0 mm | In distribution |
| 5009-3-200S | Diameter: 5.0 Millimeter | In distribution |
| 5018-6-200 | Length 200.0 mm | In distribution |
| 5014-6-180S | Diameter: 6.0 Millimeter | In distribution |
| 5020-7-200 | Length 200.0 mm | In distribution |
| 5023-4-180 | Length 180.0 mm | In distribution |
| 5010-5-200S | Diameter: 6.0 Millimeter | In distribution |
| 5014-3-180S | Length 180.0 mm | In distribution |
| 5036-2-110 | Diameter: 3.0 Millimeter | In distribution |
| 5008-3-150S | Length 150.0 mm | In distribution |
| 5008-4-150S | Diameter: 4.0 Millimeter | In distribution |
| 5021-7-150 | Length 150.0 mm | In distribution |
| 5020-8-250 | Length 250.0 mm | In distribution |
| 5013-4-150S | Length 150.0 mm | In distribution |
| 5008-2-150S | Diameter: 4.0 Millimeter | In distribution |
| 5019-8-200 | Diameter: 6.0 Millimeter | In distribution |
| 5013-8-120S | Diameter: 4.0 Millimeter | In distribution |
| 5070-4-812 | Diameter: 2.0 Millimeter | In distribution |
| 5023-1-090 | Diameter: 4.0 Millimeter | In distribution |
| 5020-6-200 | Length 200.0 mm | In distribution |
| 5038-1-110S | In distribution | |
| 5021-8-250 | Diameter: 6.0 Millimeter | In distribution |
| 5036-1-580 | Diameter: 3.0 Millimeter | In distribution |
| 5023-3-120 | Length 120.0 mm | In distribution |
| 5023-6-180 | Diameter: 4.0 Millimeter | In distribution |
| 5009-5-200S | Diameter: 5.0 Millimeter | In distribution |
| 5070-5-815 | Diameter: 2.0 Millimeter | In distribution |
| 5015-7-250 | Diameter: 5.0 Millimeter | In distribution |
| 5015-4-150 | Length 150.0 mm | In distribution |
| 5027-4-120 | Length 120.0 mm | In distribution |
| 5023-5-120S | Diameter: 4.0 Millimeter | In distribution |
| 5017-3-180S | Length 180.0 mm | In distribution |
| 5038-2-080S | Diameter: 3.0 Millimeter | In distribution |
| 5013-9-120S | Diameter: 4.0 Millimeter | In distribution |
| 5018-5-120 | Length 120.0 mm | In distribution |
| 5018-3-180 | Length 180.0 mm | In distribution |
| 5017-4-150S | Diameter: 5.0 Millimeter | In distribution |
| 5050-5-250 | Diameter: 6.0 Millimeter | In distribution |
| 5023-6-180S | Diameter: 4.0 Millimeter | In distribution |
| 5070-3-310 | Length 33.0 mm | In distribution |
| 5013-2-120S | Diameter: 4.0 Millimeter | In distribution |
| 5023-5-120 | Length 120.0 mm | In distribution |
| 5038-5-080 | Length 80.0 mm | In distribution |
| 5070-5-312 | Length 53.0 mm | In distribution |
| 5065-3-312 | Diameter: 2.0 Millimeter | In distribution |
| 5014-3-150S | Length 150.0 mm | In distribution |
| 5018-6-150 | Diameter: 5.0 Millimeter | In distribution |
| 5019-6-180 | Diameter: 6.0 Millimeter | In distribution |
| 5018-5-150 | Diameter: 5.0 Millimeter | In distribution |
| 5018-6-150S | Diameter: 5.0 Millimeter | In distribution |
| 5017-9-120S | Diameter: 5.0 Millimeter | In distribution |
| 5070-4-312 | Length 43.0 mm | In distribution |
| 5016-5-118 | Length 150.0 mm | In distribution |
| 5038-2-110 | Length 110.0 mm | In distribution |
| 5023-6-150S | Diameter: 4.0 Millimeter | In distribution |
| 5065-6-020 | Length 60.0 mm | In distribution |
| 5030-4-250 | Length 250.0 mm | In distribution |
| 5013-3-150S | Length 150.0 mm | In distribution |
| 5027-1-090 | Length 90.0 mm | In distribution |
| 5023-6-150 | Length 150.0 mm | In distribution |
| 5027-2-090 | Length 90.0 mm | In distribution |
| 5017-9-150S | Diameter: 5.0 Millimeter | In distribution |
| 5014-4-200S | Diameter: 6.0 Millimeter | In distribution |
| 5027-3-090 | Length 90.0 mm | In distribution |
| 5013-3-090S | Diameter: 4.0 Millimeter | In distribution |
| 5030-4-200 | Diameter: 4.0 Millimeter | In distribution |
| 5027-1-040 | Diameter: 4.0 Millimeter | In distribution |
| 5020-7-180 | Diameter: 5.0 Millimeter | In distribution |
| 5018-3-120 | Diameter: 5.0 Millimeter | In distribution |
| 5009-4-200S | Diameter: 5.0 Millimeter | In distribution |
| 5016-5-122 | Diameter: 5.0 Millimeter | In distribution |
| 5038-1-080 | Length 80.0 mm | In distribution |
| 5010-7-250S | Length 250.0 mm | In distribution |
| 5045-5-200 | Length 200.0 mm | In distribution |
| 5017-6-150S | Diameter: 5.0 Millimeter | In distribution |
| 5014-8-150S | Diameter: 6.0 Millimeter | In distribution |
| 5036-1-110 | Diameter: 3.0 Millimeter | In distribution |
| 5010-9-250S | Length 250.0 mm | In distribution |
| 5036-2-080 | Length 80.0 mm | In distribution |
| 5020-7-150 | Length 150.0 mm | In distribution |
| 5047-1-030 | Diameter: 3.0 Millimeter | In distribution |
| 5017-6-200S | Diameter: 5.0 Millimeter | In distribution |
| 5023-2-090 | Diameter: 4.0 Millimeter | In distribution |
| 5027-5-150 | Length 150.0 mm | In distribution |
| 5020-3-120 | Diameter: 5.0 Millimeter | In distribution |
| 5017-4-180S | Diameter: 5.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
| gSource | Gsource, LLC. | 74 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211508 | 2021-10-05 |
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.