MaxLock Extreme™
OrthoLink™ Medial Wedge Osteotomy Plate
22manufacturers in China registered for this device type
157catalogue numbers in this listing
4510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2025-02-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Outer diameter 2 to 30 mm; length 8 to 65 mm; angle 4 to 8 ° |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MXL-002-4A | In distribution | |
| MFT-021-35-26 | Length 26 mm | In distribution |
| MFT-021-35-10 | Length 10 mm | In distribution |
| MFT-011-27-28 | Length 28 mm | In distribution |
| MFT-011-40P-325 | Length 32.5 mm | In distribution |
| TMT-002-23SL | Size Small | In distribution |
| MFT-011-27-14 | Length 14 mm | In distribution |
| VAR-031-35-46 | Outer Diameter 3.5 mm | In distribution |
| MXL-002-8 | In distribution | |
| MXL-002-10A | In distribution | |
| TMT-002-12ML | Size Standard | In distribution |
| DTX-002-MSR | Size Short | In distribution |
| MXL-002-0A | In distribution | |
| MXL-002-7A | In distribution | |
| MFT-011-40-40 | Outer Diameter 4 mm | In distribution |
| VAR-031-35-30 | Length 30 mm | In distribution |
| MXL-002-6 | In distribution | |
| MFT-011-40-20 | Outer Diameter 4 mm | In distribution |
| SP-DFX-002-8L | Size Extra Long | In distribution |
| MFT-011-40-55 | Outer Diameter 4 mm | In distribution |
| MFT-021-35-30 | Outer Diameter 3.5 mm | In distribution |
| EDL-001-M | In distribution | |
| DTX-002-MSL | Size Short | In distribution |
| VAR-031-35-50 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-40-08 | Outer Diameter 4 mm | In distribution |
| DTX-002-MAL | In distribution | |
| MFT-011-35-475 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-27-08 | Length 8 mm | In distribution |
| TMT-002-23MR | Size Standard | In distribution |
| MFT-011-40-60 | Outer Diameter 4 mm | In distribution |
| MFT-011-35-425 | Outer Diameter 3.5 mm | In distribution |
| MFT-021-35-375 | Outer Diameter 3.5 mm | In distribution |
| VAR-032-24 | Outer Diameter 2.4 mm | In distribution |
| MFT-011-27-30 | Length 30 mm | In distribution |
| DFX-002-SL | Size Short | In distribution |
| MTP-002-SR | Size Standard | In distribution |
| VAR-031-35-34 | Outer Diameter 3.5 mm | In distribution |
| MFT-021-35-28 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-35-08 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-27-26 | Outer Diameter 2.7 mm | In distribution |
| DFX-002-LL | Size Long | In distribution |
| MFT-021-35-12 | Outer Diameter 3.5 mm | In distribution |
| MFT-021-35-35 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-35-28 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-27-10 | Length 10 mm | In distribution |
| MFT-002-Y | In distribution | |
| MFT-011-40P-30 | Length 30 mm | In distribution |
| DTX-002-MLL | Size Long | In distribution |
| MXL-002-2A | In distribution | |
| MCS-002-MCR | In distribution | |
| MCS-002-4LP | Angle 4 ° | In distribution |
| VAR-031-35-44 | Length 44 mm | In distribution |
| SP-DFX-002-8R | Size Extra Long | In distribution |
| MFT-011-35-26 | Length 26 mm | In distribution |
| MFT-011-40-24 | Outer Diameter 4 mm | In distribution |
| DTX-002-MMR | Size Medium | In distribution |
| MFT-011-40-10 | Length 10 mm | In distribution |
| MXL-002-1A | In distribution | |
| MFT-011-35-12 | Length 12 mm | In distribution |
| MFT-011-35-10 | Length 10 mm | In distribution |
| MFT-011-27-22 | Outer Diameter 2.7 mm | In distribution |
| MFT-011-40-45 | Length 45 mm | In distribution |
| DTX-002-MLR | Size Long | In distribution |
| VAR-031-35-22 | Outer Diameter 3.5 mm | In distribution |
| EDL-001-00 | In distribution | |
| VAR-031-35-36 | Length 36 mm | In distribution |
| MFT-011-35-35 | Length 35 mm | In distribution |
| MFT-011-27-16 | Length 16 mm | In distribution |
| MFT-011-27-20 | Length 20 mm | In distribution |
| MFT-021-35-425 | Length 42.5 mm | In distribution |
| VAR-031-35-12 | Outer Diameter 3.5 mm | In distribution |
| MFT-011-35-22 | Length 22 mm | In distribution |
| MFT-011-40-12 | Length 12 mm | In distribution |
| MFT-011-40P-28 | Outer Diameter 4 mm | In distribution |
| MCS-002-NR | Size Standard | In distribution |
| MXL-002-3A | In distribution | |
| TMT-002-12SR | Size Small | In distribution |
| MFT-011-40-375 | Length 37.5 mm | In distribution |
| MFT-011-40-325 | Length 32.5 mm | In distribution |
| MFT-011-40-26 | Outer Diameter 4 mm | In distribution |
| CLA-002-LATXR | Size Long | Withdrawn |
| VAR-031-35-65 | Length 65 mm | Withdrawn |
| MXL-002-4C | Withdrawn | |
| DHX-002-M10R | Withdrawn | |
| VAR-031-27-30 | Outer Diameter 2.7 mm | Withdrawn |
| MFT-011-27-55 | Outer Diameter 2.7 mm | Withdrawn |
| MFT-011-40P-35 | Outer Diameter 4 mm | Withdrawn |
| CLA-002-LATXL | Size Long | Withdrawn |
| MFT-011-35-65 | Length 65 mm | Withdrawn |
| ANK-002-LTTPL | Withdrawn | |
| SP-MCS-002-NC-R | Withdrawn | |
| ANK-002-TTCL | Withdrawn | |
| PUX-002-15L | Withdrawn | |
| VAR-031-27-50 | Outer Diameter 2.7 mm | Withdrawn |
| MCS-002-4RP | Angle 4 ° | Withdrawn |
| ANK-002-ATT | Withdrawn | |
| MFT-011-35-55 | Outer Diameter 3.5 mm | Withdrawn |
| MOW-003-3 | Outer Diameter 3 mm | Withdrawn |
| SP-DFX-002-10L | Size Extra Long | Withdrawn |
| DHX-002-L12R | Withdrawn | |
| MCS-002-8RP | Angle 8 ° | Withdrawn |
| VAR-031-27-28 | Outer Diameter 2.7 mm | Withdrawn |
| PUX-002-13L | Withdrawn | |
| VAR-031-27-32 | Outer Diameter 2.7 mm | Withdrawn |
| MCS-002-NLP | Size Neutral | Withdrawn |
| MFT-011-27-60 | Length 60 mm | Withdrawn |
| VAR-031-35-55 | Outer Diameter 3.5 mm | Withdrawn |
| MFT-011-40P-475 | Outer Diameter 4 mm | Withdrawn |
| MCS-002-NBP | Withdrawn | |
| MXL-002-0C | Withdrawn | |
| SP-MFT-005 | Withdrawn | |
| DHX-002-L12L | Withdrawn | |
| SP-DFX-002-10R | Size Extra Long | Withdrawn |
| MFT-011-27-40 | Length 40 mm | Withdrawn |
| VAR-031-27-10 | Outer Diameter 2.7 mm | Withdrawn |
| COW-003-08 | Outer Diameter 8 mm | Withdrawn |
| COW-003-02 | Outer Diameter 2 mm | Withdrawn |
| PUX-002-15R | Withdrawn | |
| MFT-011-40P-425 | Length 42.5 mm | Withdrawn |
| MFT-011-40P-20 | Length 20 mm | Withdrawn |
| MFT-002-4 | Withdrawn | |
| MFT-011-27-50 | Length 50 mm | Withdrawn |
| CLA-002-ANTXL | Size Extra Large | Withdrawn |
| CLA-002-ANTS | Size Short | Withdrawn |
| MCS-002-4BP | Angle 4 ° | Withdrawn |
| CLA-002-ANTL | Size Long | Withdrawn |
| MFT-011-27-325 | Outer Diameter 2.7 mm | Withdrawn |
| VAR-031-35-60 | Outer Diameter 3.5 mm | Withdrawn |
| MCS-002-NAP | Withdrawn | |
| ANK-002-LTT | Withdrawn | |
| MCS-002-8LP | Angle 8 ° | Withdrawn |
| MFT-011-40P-60 | Length 60 mm | Withdrawn |
| DHX-002-M08R | Withdrawn | |
| ANK-002-TTCR | Withdrawn | |
| CLA-002-LATR | Size Standard | Withdrawn |
| SP-DFX-R5L | Withdrawn | |
| MFT-011-27-65 | Outer Diameter 2.7 mm | Withdrawn |
| DHX-002-L08L | Withdrawn | |
| PKT-002-H30A | Outer Diameter 30 mm | Withdrawn |
| MFT-011-40P-375 | Length 37.5 mm | Withdrawn |
| VAR-031-27-26 | Length 26 mm | Withdrawn |
| DHX-002-M08L | Withdrawn | |
| DHX-002-M10L | Withdrawn | |
| VAR-031-27-22 | Length 22 mm | Withdrawn |
| CLA-002-LATL | Size Standard | Withdrawn |
| MFT-011-40P-50 | Length 50 mm | Withdrawn |
| SP-MCS-001-B | Withdrawn | |
| MXL-002-1C | Withdrawn | |
| MXL-002-2C | Withdrawn | |
| MOW-003-6 | Outer Diameter 6 mm | Withdrawn |
| SP-MFT-001 | Withdrawn | |
| CLA-002-SUP6 | Withdrawn | |
| COW-003-07 | Outer Diameter 7 mm | Withdrawn |
| MFT-011-27-45 | Outer Diameter 2.7 mm | Withdrawn |
| MCS-002-8BP | Angle 8 ° | Withdrawn |
| SP-DFX-R5R | Withdrawn | |
| PUX-002-13R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191711 | 2019-07-17 |
| K181587 | 2018-10-05 |
| K090139 | 2009-10-27 |
| K090582 | 2009-07-02 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-08-22 | Not classified | Nonconforming Material/Component | The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing. | 2,722 units | 2012-02-19 |
| 2011-07-06 | Not classified | Nonconforming Material/Component | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. | 61 trays | 2012-09-10 |
| 2007-09-04 | Not classified | Component change control | Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened. | 267 plates/52 DRL System Trays | 2011-05-20 |
| 2006-08-03 | Not classified | Other | The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized. | 180 | 2012-09-10 |
| 2005-11-01 | Not classified | Other | Screwdriver pilot taper tip can break during surgery. | 14 | 2012-04-25 |
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.