Hoffmann
Pin to Rod Coupling, multiplanar Dia 4,5,6mm, Dia 5,8,11mm
17manufacturers in China registered for this device type
239catalogue numbers in this listing
11510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K073076 |
| Record published | 2016-09-22 |
| Record revised | 2026-06-24 (version 9) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 10, pack of 100 |
| Sizes | Length 2 to 650 mm; angle 30 to 90 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4933-2-140 | Diameter: 140.0 Millimeter | In distribution |
| 4934-5-210 | Diameter: 210.0 Millimeter | In distribution |
| 4980-3-260S | Diameter: 15.0 Millimeter | In distribution |
| 4934-1-060 | In distribution | |
| 4933-3-155 | Diameter: 155.0 Millimeter | In distribution |
| 4934-6-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-1-060 | Length 60.0 mm | In distribution |
| 4933-4-180 | Diameter: 180.0 Millimeter | In distribution |
| 4934-7-180 | In distribution | |
| 4935-0-030 | In distribution | |
| 4934-3-140 | Diameter: 140.0 Millimeter | In distribution |
| 4922-9-050 | In distribution | |
| 4934-0-190 | In distribution | |
| 4922-9-140 | In distribution | |
| 4933-1-001 | In distribution | |
| 4922-8-650 | Length 650.0 mm | In distribution |
| 4922-2-020 | In distribution | |
| 4933-6-210 | Diameter: 210.0 Millimeter | In distribution |
| 4934-3-210 | Diameter: 210.0 Millimeter | In distribution |
| 4922-8-600 | Diameter: 11.0 Millimeter | In distribution |
| 4933-2-120 | Diameter: 120.0 Millimeter | In distribution |
| 4922-8-400 | Length 400.0 mm | In distribution |
| 4933-1-520 | Length 20.0 mm | In distribution |
| 4934-0-210 | In distribution | |
| 4933-3-240 | Diameter: 240.0 Millimeter | In distribution |
| 4934-3-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-2-080 | Diameter: 80.0 Millimeter | In distribution |
| 4941-2-020 | Screw Holes: 4.0 Holes | In distribution |
| 5079-6-030 | Length 30.0 mm | In distribution |
| 4922-8-250 | Diameter: 11.0 Millimeter | In distribution |
| 4960-3-015 | In distribution | |
| 4933-8-030 | Diameter: 1.8 Millimeter | In distribution |
| 4933-1-022 | In distribution | |
| 4933-7-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-1-020 | In distribution | |
| 4933-2-155 | Diameter: 155.0 Millimeter | In distribution |
| 5028-8-250 | Length 250.0 mm | In distribution |
| 4934-8-140 | In distribution | |
| 4933-1-712 | Length 4.0 mm | In distribution |
| 4934-2-155 | Diameter: 155.0 Millimeter | In distribution |
| 4933-4-140 | Diameter: 140.0 Millimeter | In distribution |
| 4934-4-140 | Diameter: 140.0 Millimeter | In distribution |
| 4935-1-100 | In distribution | |
| 4921-2-120 | In distribution | |
| 4933-0-401 | In distribution | |
| 4941-1-058 | In distribution | |
| 5048-5-065 | Diameter: 5.0 Millimeter | In distribution |
| 4934-7-140 | In distribution | |
| 4960-2-030 | Angle 90.0 ° | In distribution |
| 4933-1-080 | Length 80.0 mm | In distribution |
| 4922-8-350 | Diameter: 11.0 Millimeter | In distribution |
| 4960-3-025 | In distribution | |
| 4922-2-240 | In distribution | |
| 4933-3-140 | Diameter: 140.0 Millimeter | In distribution |
| 5048-5-100 | Length 100.0 mm | In distribution |
| 4933-1-011 | In distribution | |
| 5079-6-090 | Length 90.0 mm | In distribution |
| 4933-1-021 | In distribution | |
| 4922-2-220 | In distribution | |
| 4934-6-210 | Diameter: 210.0 Millimeter | In distribution |
| 4933-1-710 | In distribution | |
| 4941-1-020 | In distribution | |
| 4941-1-010 | In distribution | |
| 4922-1-220 | In distribution | |
| 4922-2-320 | In distribution | |
| 4933-1-350 | Length 350.0 mm | In distribution |
| 4933-1-540 | Length 40.0 mm | In distribution |
| 4980-3-210S | Diameter: 15.0 Millimeter | In distribution |
| 4934-5-140 | Diameter: 140.0 Millimeter | In distribution |
| 5048-5-150 | Length 150.0 mm | In distribution |
| 4934-5-155 | Diameter: 155.0 Millimeter | In distribution |
| 4934-2-180 | Diameter: 180.0 Millimeter | In distribution |
| 4922-8-100 | Length 100.0 mm | In distribution |
| 4922-9-941S | In distribution | |
| 4933-5-120 | Diameter: 120.0 Millimeter | In distribution |
| 4921-0-000 | Diameter: 20.0 Millimeter | In distribution |
| 4922-8-300 | Diameter: 11.0 Millimeter | In distribution |
| 4933-1-030 | Length 30.0 mm | In distribution |
| 4980-2-020S | Screw Holes: 5.0 Holes | In distribution |
| 4933-7-140 | Diameter: 140.0 Millimeter | In distribution |
| 4960-1-060 | In distribution | |
| 4933-3-180 | Diameter: 180.0 Millimeter | In distribution |
| 4922-1-030 | In distribution | |
| 4922-2-160 | In distribution | |
| 4933-1-100 | Length 100.0 mm | In distribution |
| 4933-6-100 | Diameter: 100.0 Millimeter | In distribution |
| 4934-4-210 | Diameter: 210.0 Millimeter | In distribution |
| 4933-8-040 | Length 450.0 mm | In distribution |
| 4980-1-010S | In distribution | |
| 4933-0-300 | In distribution | |
| 4934-1-130 | In distribution | |
| 4922-1-006 | In distribution | |
| 4920-2-181 | In distribution | |
| 4960-3-020 | In distribution | |
| 4933-7-210 | Diameter: 210.0 Millimeter | In distribution |
| 4922-8-450 | Diameter: 11.0 Millimeter | In distribution |
| 4933-1-200 | Length 200.0 mm | In distribution |
| 4935-0-010 | In distribution | |
| 4933-8-010 | Length 450.0 mm | In distribution |
| 4933-2-240 | Diameter: 240.0 Millimeter | In distribution |
| 4933-1-644 | Length 44.0 mm | In distribution |
| 4922-2-140 | In distribution | |
| 4933-0-801 | In distribution | |
| 4933-4-155 | Diameter: 155.0 Millimeter | In distribution |
| 4933-5-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-8-020 | Length 450.0 mm | In distribution |
| 4933-3-120 | Diameter: 120.0 Millimeter | In distribution |
| 4933-2-210 | Diameter: 210.0 Millimeter | In distribution |
| 4933-6-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-0-402 | In distribution | |
| 4933-5-155 | Diameter: 155.0 Millimeter | In distribution |
| 4933-7-155 | Diameter: 155.0 Millimeter | In distribution |
| 4934-6-120 | Diameter: 120.0 Millimeter | In distribution |
| 4922-7-220 | Length 220.0 mm | In distribution |
| 4933-5-210 | Diameter: 210.0 Millimeter | In distribution |
| 4941-0-015 | Diameter: 15.0 Millimeter | In distribution |
| 4933-0-120 | In distribution | |
| 4933-0-400 | In distribution | |
| 4940-2-200 | In distribution | |
| 4933-1-010 | In distribution | |
| 4933-4-210 | Diameter: 210.0 Millimeter | In distribution |
| 4922-9-950 | In distribution | |
| 4933-4-240 | Diameter: 240.0 Millimeter | In distribution |
| 4922-2-340 | In distribution | |
| 4933-4-100 | Diameter: 100.0 Millimeter | In distribution |
| 4933-1-150 | Length 150.0 mm | In distribution |
| 5029-8-200 | Diameter: 8.0 Millimeter | In distribution |
| 4960-1-010 | In distribution | |
| 5028-8-350 | Length 350.0 mm | In distribution |
| 4934-3-100 | Diameter: 100.0 Millimeter | In distribution |
| 4934-1-008 | In distribution | |
| 4960-3-030 | In distribution | |
| 4922-1-020 | In distribution | |
| 4922-1-003 | In distribution | |
| 4933-0-802 | In distribution | |
| 983031 | In distribution | |
| 5048-5-250 | Length 250.0 mm | In distribution |
| 5028-8-065 | Diameter: 8.0 Millimeter | In distribution |
| 4922-1-010 | In distribution | |
| 4933-2-180 | Diameter: 180.0 Millimeter | In distribution |
| 4934-2-140 | Diameter: 140.0 Millimeter | In distribution |
| 4922-8-550 | Diameter: 11.0 Millimeter | In distribution |
| 4933-3-100 | Diameter: 100.0 Millimeter | In distribution |
| 4935-0-040 | In distribution | |
| 4933-1-702 | In distribution | |
| 4980-3-150S | Diameter: 15.0 Millimeter | In distribution |
| 4922-8-200 | Diameter: 11.0 Millimeter | In distribution |
| 4960-2-020 | In distribution | |
| 4933-3-210 | Diameter: 210.0 Millimeter | In distribution |
| 4922-1-025 | In distribution | |
| 4934-3-155 | Diameter: 155.0 Millimeter | In distribution |
| 5079-6-060 | Length 60.0 mm | In distribution |
| 5048-5-200 | Length 200.0 mm | In distribution |
| 4933-1-004 | In distribution | |
| 4920-3-010 | Length 2.0 mm | In distribution |
| 4933-1-711 | In distribution | |
| 4933-5-100 | Diameter: 100.0 Millimeter | In distribution |
| 4933-1-002 | In distribution | |
| 4980-3-330S | Length 330.0 mm | In distribution |
| 4933-1-688 | Length 88.0 mm | In distribution |
| 4922-1-007 | In distribution | |
| 4933-2-100 | Diameter: 100.0 Millimeter | In distribution |
| 4933-1-003 | In distribution | |
| 4934-6-100 | Diameter: 100.0 Millimeter | In distribution |
| 4934-4-155 | Diameter: 155.0 Millimeter | In distribution |
| 4933-1-530 | Length 30.0 mm | In distribution |
| 4933-1-720 | In distribution | |
| 4933-1-250 | Length 250.0 mm | In distribution |
| 4922-9-240 | Diameter: 5.0 Millimeter | In distribution |
| 5079-6-040 | Diameter: 3.0 Millimeter | In distribution |
| 5028-8-150 | Length 150.0 mm | In distribution |
| 4934-0-270 | In distribution | |
| 4933-5-080 | Diameter: 80.0 Millimeter | In distribution |
| 5048-5-300 | Diameter: 5.0 Millimeter | In distribution |
| 5079-6-150 | Length 150.0 mm | In distribution |
| 4934-0-360 | In distribution | |
| 4980-3-020S | Diameter: 15.0 Millimeter | In distribution |
| 4933-1-005 | In distribution | |
| 4934-3-120 | Diameter: 120.0 Millimeter | In distribution |
| 5079-6-120 | Length 120.0 mm | In distribution |
| 4922-9-940S | In distribution | |
| 4934-2-210 | Diameter: 210.0 Millimeter | In distribution |
| 4933-4-120 | Diameter: 120.0 Millimeter | In distribution |
| 4934-4-100 | Diameter: 100.0 Millimeter | In distribution |
| 4941-2-120 | In distribution | |
| 4934-8-180 | In distribution | |
| 5049-5-150 | Diameter: 5.0 Millimeter | In distribution |
| 4933-6-140 | Diameter: 140.0 Millimeter | In distribution |
| 4941-1-100 | In distribution | |
| 4934-5-120 | Diameter: 120.0 Millimeter | In distribution |
| 4933-6-155 | Diameter: 155.0 Millimeter | In distribution |
| 4934-5-100 | Diameter: 100.0 Millimeter | In distribution |
| 4933-0-180 | In distribution | |
| 4941-2-200 | Screw Holes: 4.0 Holes | In distribution |
| 4922-8-500 | Length 500.0 mm | In distribution |
| 4933-6-120 | Diameter: 120.0 Millimeter | In distribution |
| 4922-8-150 | Diameter: 11.0 Millimeter | In distribution |
| 5079-6-050 | Diameter: 3.0 Millimeter | In distribution |
| 4934-1-016 | In distribution | |
| 4941-2-140 | Angle 30.0 ° | In distribution |
| 4934-2-100 | Diameter: 100.0 Millimeter | In distribution |
| 4934-8-100 | In distribution | |
| 5028-8-450 | Length 450.0 mm | In distribution |
| 4934-1-150 | In distribution | |
| 4934-6-140 | Diameter: 140.0 Millimeter | In distribution |
| 4980-2-010S | Screw Holes: 5.0 Holes | In distribution |
| 4960-3-010 | In distribution | |
| 4922-9-000 | In distribution | |
| 4934-7-100 | In distribution | |
| 4933-1-713 | In distribution | |
| 4934-6-155 | Diameter: 155.0 Millimeter | In distribution |
| 4933-1-701 | In distribution | |
| 4922-9-060 | In distribution | |
| 4933-0-140 | In distribution | |
| 5049-5-065 | Diameter: 5.0 Millimeter | In distribution |
| 4960-3-000 | In distribution | |
| 4933-5-140 | Diameter: 140.0 Millimeter | In distribution |
| 4933-0-800 | In distribution | |
| 4921-2-160 | Angle 90.0 ° | In distribution |
| 4933-1-300 | Length 300.0 mm | In distribution |
| 4960-1-020 | In distribution | |
| 4934-2-120 | Diameter: 120.0 Millimeter | In distribution |
| 4933-2-270 | Diameter: 270.0 Millimeter | In distribution |
| 4934-5-180 | Diameter: 180.0 Millimeter | In distribution |
| 4933-1-560 | Length 60.0 mm | In distribution |
| 4933-7-100 | Diameter: 100.0 Millimeter | In distribution |
| 4920-1-100 | In distribution | |
| 4922-2-120 | In distribution | |
| 4933-7-120 | Diameter: 120.0 Millimeter | In distribution |
| 4933-0-700 | In distribution | |
| 4980-3-440S | Diameter: 15.0 Millimeter | In distribution |
| 4922-1-015 | In distribution | |
| 4933-1-120 | Length 120.0 mm | In distribution |
| 4934-4-180 | Diameter: 180.0 Millimeter | In distribution |
| 4935-0-020 | In distribution | |
| 4933-1-400 | Length 400.0 mm | In distribution |
| 4934-4-120 | Diameter: 120.0 Millimeter | In distribution |
| 4933-0-100 | In distribution | |
| 4922-1-002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Smith & Nephew, Inc. | 204 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253202 | 2025-12-19 |
| K233741 | 2023-12-21 |
| K203568 | 2021-02-01 |
| K182968 | 2019-01-25 |
| K163656 | 2017-04-14 |
| K161753 | 2016-11-15 |
| K153377 | 2016-04-11 |
| K122284 | 2012-10-24 |
| K121252 | 2012-07-25 |
| K113327 | 2012-03-29 |
| K111786 | 2012-01-26 |
Recalls Naming This Product
12 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 |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 4,505 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 6,244 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 7,571 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 9,658 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 9,405 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 5,439 units | |
| Stryker GmbH | 510(k) number | 2026-07-01 | Class II | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | 5,664 units | |
| Stryker GmbH | 510(k) number | 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 578 | 2021-02-04 |
| Stryker GmbH | 510(k) number | 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 832 | 2021-02-04 |
| Stryker GmbH | 510(k) number | 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 1355 | 2021-02-04 |
| Stryker GmbH | 510(k) number | 2018-08-28 | Class II | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in p | 867 | 2021-02-04 |
| Stryker GmbH | 510(k) number | 2018-07-26 | Class II | Under Investigation by firm | When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial | 233 | 2020-05-26 |
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 |
|---|---|---|---|---|---|
| 2024-05-09 | Class II | Process change control | The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. | 39 devices | |
| 2023-02-07 | Class II | Process change control | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked bet | 488 units | |
| 2018-03-12 | Class II | Labeling mix-ups | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling | 18 | 2020-05-21 |
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.