Tritanium PL
Posterior Lumbar Cage
14manufacturers in China registered for this device type
180catalogue numbers in this listing
17510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-11-15 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Angle 0 to 12 °; length 23 to 32 mm; height 6 to 16 mm; width 9 to 11 mm; depth 9 to 11 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48957150 | Depth 9.0 mm | In distribution |
| 48956060 | Width 11.0 mm | In distribution |
| 48957100 | Angle 0.0 ° | In distribution |
| 48957076 | Angle 6.0 ° | In distribution |
| 48950136 | Width 9.0 mm | In distribution |
| 48951142 | Height 14.0 mm | In distribution |
| 48952122 | Height 12.0 mm | In distribution |
| 48950110 | Length 23.0 mm | In distribution |
| 48957140 | Height 14.0 mm | In distribution |
| 48957106 | Height 10.0 mm | In distribution |
| 48951120 | Angle 0.0 ° | In distribution |
| 48956130 | Height 13.0 mm | In distribution |
| 48956122 | Length 32.0 mm | In distribution |
| 48950096 | Angle 6.0 ° | In distribution |
| 48957070 | Angle 0.0 ° | In distribution |
| 48957092 | Length 32.0 mm | In distribution |
| 48951122 | Length 23.0 mm | In distribution |
| 48950160 | Angle 0.0 ° | In distribution |
| 48955156 | Width 11.0 mm | In distribution |
| 48952090 | Length 28.0 mm | In distribution |
| 48950126 | Length 23.0 mm | In distribution |
| 48957132 | Length 32.0 mm | In distribution |
| 48954086 | Angle 6.0 ° | In distribution |
| 48955096 | Width 11.0 mm | In distribution |
| 48952092 | Angle 12.0 ° | In distribution |
| 48957130 | Depth 9.0 mm | In distribution |
| 48952102 | Width 9.0 mm | In distribution |
| 48955066 | Length 28.0 mm | In distribution |
| 48951110 | Width 11.0 mm | In distribution |
| 48956126 | Depth 11.0 mm | In distribution |
| 48956086 | Depth 11.0 mm | In distribution |
| 48951106 | Width 11.0 mm | In distribution |
| 48951066 | Length 23.0 mm | In distribution |
| 48956160 | Height 16.0 mm | In distribution |
| 48953130 | Width 11.0 mm | In distribution |
| 48956070 | Angle 0.0 ° | In distribution |
| 48951060 | Length 23.0 mm | In distribution |
| 48950130 | Angle 0.0 ° | In distribution |
| 48955076 | Height 7.0 mm | In distribution |
| 48956156 | Height 15.0 mm | In distribution |
| 48957066 | Angle 6.0 ° | In distribution |
| 48957160 | Angle 0.0 ° | In distribution |
| 48955106 | Length 28.0 mm | In distribution |
| 48951150 | Width 11.0 mm | In distribution |
| 48953092 | Width 11.0 mm | In distribution |
| 48953090 | Width 11.0 mm | In distribution |
| 48954106 | Height 10.0 mm | In distribution |
| 48955126 | Length 28.0 mm | In distribution |
| 48950112 | Length 23.0 mm | In distribution |
| 48953150 | Length 28.0 mm | In distribution |
| 48956112 | Depth 11.0 mm | In distribution |
| 48957126 | Height 12.0 mm | In distribution |
| 48952080 | Width 9.0 mm | In distribution |
| 48956092 | Angle 12.0 ° | In distribution |
| 48956150 | Angle 0.0 ° | In distribution |
| 48956152 | Length 32.0 mm | In distribution |
| 48954096 | Height 9.0 mm | In distribution |
| 48950106 | Width 9.0 mm | In distribution |
| 48954116 | Angle 6.0 ° | In distribution |
| 48957166 | Length 32.0 mm | In distribution |
| 48951116 | Length 23.0 mm | In distribution |
| 48955116 | Angle 6.0 ° | In distribution |
| 48952130 | Length 28.0 mm | In distribution |
| 48950156 | Angle 6.0 ° | In distribution |
| 48951166 | Length 23.0 mm | In distribution |
| 48952112 | Width 9.0 mm | In distribution |
| 48952160 | Width 9.0 mm | In distribution |
| 48956076 | Angle 6.0 ° | In distribution |
| 48953132 | Height 13.0 mm | In distribution |
| 48953112 | Angle 12.0 ° | In distribution |
| 48950146 | Angle 6.0 ° | In distribution |
| 48951156 | Width 11.0 mm | In distribution |
| 48951100 | Width 11.0 mm | In distribution |
| 48951126 | Angle 6.0 ° | In distribution |
| 48953100 | Width 11.0 mm | In distribution |
| 48957080 | Length 32.0 mm | In distribution |
| 48956080 | Depth 11.0 mm | In distribution |
| 48951130 | Angle 0.0 ° | In distribution |
| 48951090 | Angle 0.0 ° | In distribution |
| 48951162 | Height 16.0 mm | In distribution |
| 48952142 | Length 28.0 mm | In distribution |
| 48956140 | Depth 11.0 mm | In distribution |
| 48957116 | Depth 9.0 mm | In distribution |
| 48956116 | Length 32.0 mm | In distribution |
| 48951102 | Width 11.0 mm | In distribution |
| 48954066 | Length 28.0 mm | In distribution |
| 48956132 | Height 13.0 mm | In distribution |
| 48952120 | Height 12.0 mm | In distribution |
| 48952110 | Width 9.0 mm | In distribution |
| 48957102 | Depth 9.0 mm | In distribution |
| 48950102 | Width 9.0 mm | In distribution |
| 48952150 | Length 28.0 mm | In distribution |
| 48950092 | Angle 12.0 ° | In distribution |
| 48956102 | Angle 12.0 ° | In distribution |
| 48951152 | Width 11.0 mm | In distribution |
| 48952060 | Height 6.0 mm | In distribution |
| 48950122 | Height 12.0 mm | In distribution |
| 48950090 | Height 9.0 mm | In distribution |
| 48955136 | Length 28.0 mm | In distribution |
| 48957142 | Height 14.0 mm | In distribution |
| 48956110 | Angle 0.0 ° | In distribution |
| 48957112 | Depth 9.0 mm | In distribution |
| 48952140 | Angle 0.0 ° | In distribution |
| 48956090 | Length 32.0 mm | In distribution |
| 48951080 | Length 23.0 mm | In distribution |
| 48955146 | Angle 6.0 ° | In distribution |
| 48957090 | Length 32.0 mm | In distribution |
| 48950132 | Height 13.0 mm | In distribution |
| 48957156 | Angle 6.0 ° | In distribution |
| 48952152 | Length 28.0 mm | In distribution |
| 48956142 | Angle 12.0 ° | In distribution |
| 48953070 | Height 7.0 mm | In distribution |
| 48953102 | Angle 12.0 ° | In distribution |
| 48957152 | Angle 12.0 ° | In distribution |
| 48954126 | Angle 6.0 ° | In distribution |
| 48953110 | Length 28.0 mm | In distribution |
| 48953142 | Angle 12.0 ° | In distribution |
| 48952132 | Width 9.0 mm | In distribution |
| 48957110 | Length 32.0 mm | In distribution |
| 48953162 | Height 16.0 mm | In distribution |
| 48954136 | Width 9.0 mm | In distribution |
| 48950120 | Angle 0.0 ° | In distribution |
| 48951160 | Width 11.0 mm | In distribution |
| 48950140 | Angle 0.0 ° | In distribution |
| 48951112 | Length 23.0 mm | In distribution |
| 48953120 | Height 12.0 mm | In distribution |
| 48951092 | Width 11.0 mm | In distribution |
| 48953060 | Angle 0.0 ° | In distribution |
| 48953140 | Angle 0.0 ° | In distribution |
| 48950142 | Length 23.0 mm | In distribution |
| 48950162 | Length 23.0 mm | In distribution |
| 48956136 | Length 32.0 mm | In distribution |
| 48954166 | Length 28.0 mm | In distribution |
| 48952162 | Length 28.0 mm | In distribution |
| 48951132 | Height 13.0 mm | In distribution |
| 48950116 | Width 9.0 mm | In distribution |
| 48954146 | Width 9.0 mm | In distribution |
| 48956120 | Depth 11.0 mm | In distribution |
| 48951146 | Length 23.0 mm | In distribution |
| 48950066 | Length 23.0 mm | In distribution |
| 48951086 | Height 8.0 mm | In distribution |
| 48950086 | Width 9.0 mm | In distribution |
| 48950076 | Width 9.0 mm | In distribution |
| 48951096 | Angle 6.0 ° | In distribution |
| 48950100 | Angle 0.0 ° | In distribution |
| 48955086 | Width 11.0 mm | In distribution |
| 48950060 | Height 6.0 mm | In distribution |
| 48956162 | Height 16.0 mm | In distribution |
| 48953152 | Angle 12.0 ° | In distribution |
| 48957060 | Length 32.0 mm | In distribution |
| 48951136 | Angle 6.0 ° | In distribution |
| 48951076 | Length 23.0 mm | In distribution |
| 48951070 | Height 7.0 mm | In distribution |
| 48956146 | Height 14.0 mm | In distribution |
| 48956066 | Length 32.0 mm | In distribution |
| 48957096 | Angle 6.0 ° | In distribution |
| 48957146 | Height 14.0 mm | In distribution |
| 48956100 | Length 32.0 mm | In distribution |
| 48953122 | Length 28.0 mm | In distribution |
| 48957120 | Depth 9.0 mm | In distribution |
| 48957162 | Angle 12.0 ° | In distribution |
| 48950152 | Width 9.0 mm | In distribution |
| 48950070 | Width 9.0 mm | In distribution |
| 48957122 | Length 32.0 mm | In distribution |
| 48957136 | Depth 9.0 mm | In distribution |
| 48955166 | Height 16.0 mm | In distribution |
| 48954076 | Width 9.0 mm | In distribution |
| 48956096 | Depth 11.0 mm | In distribution |
| 48954156 | Length 28.0 mm | In distribution |
| 48956106 | Height 10.0 mm | In distribution |
| 48952100 | Width 9.0 mm | In distribution |
| 48950166 | Angle 6.0 ° | In distribution |
| 48953080 | Angle 0.0 ° | In distribution |
| 48950080 | Angle 0.0 ° | In distribution |
| 48956166 | Length 32.0 mm | In distribution |
| 48950150 | Height 15.0 mm | In distribution |
| 48953160 | Angle 0.0 ° | In distribution |
| 48952070 | Height 7.0 mm | In distribution |
| 48957086 | Height 8.0 mm | In distribution |
| 48951140 | Height 14.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200613 | 2020-04-15 |
| K173476 | 2018-01-18 |
| K162262 | 2016-11-09 |
| K160955 | 2016-07-21 |
| K160715 | 2016-07-08 |
| K151726 | 2016-01-20 |
| K152651 | 2015-12-15 |
| K152304 | 2015-11-19 |
| K143616 | 2015-03-05 |
| K141217 | 2014-07-16 |
| K093864 | 2010-03-11 |
| K093704 | 2009-12-23 |
| K090816 | 2009-04-24 |
| K090166 | 2009-04-22 |
| K083661 | 2009-02-27 |
| K082014 | 2008-07-28 |
| K080758 | 2008-03-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Spine | UDI-DI | 2018-11-28 | Class II | Under Investigation by firm | The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively. | 28,461 | 2020-05-28 |
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 |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, 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.