TrellOss™-L MPF
TrellOss-L MPF is a 3D-printed lateral interbody fusion cage made from titanium alloy. Its structural frame contains a porous lattice and two large vertical cavities for bone graft. The…
TrellOss-L MPF is a 3D-printed lateral interbody fusion cage made from titanium alloy. Its structural frame contains a porous lattice and two large vertical cavities for bone graft.
The cage is used with autograft and/or allograft and supplemental fixation. It can be combined with Timberline MPF plates and screws; the plates are offered with one to four screw holes and secured with cover plates.
Listed Item
80-Cell Soft Case, 18-22mm x 14°
Lordosis and Fixation
Interbody implants with 14 degrees of lordosis or more are restricted to L2-L5 and require at least a one-hole Timberline MPF plate-and-screw construct. The cages are supplied sterile, while the related plate and screw implants are supplied nonsterile.
14manufacturers in China registered for this device type
121catalogue numbers in this listing
4510(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 | Nexxt Spine LLC, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K192687 |
| Record published | 2020-03-02 |
| Record revised | 2023-04-04 (version 3) |
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, manufacturing date |
| Sizes | Length 40 to 60 mm; width 18 to 26 mm; height 8 to 18 mm; angle 0 to 30 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150H5508 | Length 55 mm | In distribution |
| 151H4510 | Length 45 mm | In distribution |
| 154H5012 | Length 50 mm | In distribution |
| 155H4512 | Length 45 mm | In distribution |
| 154H5510 | Length 55 mm | In distribution |
| 155H5512 | Length 55 mm | In distribution |
| 155H5516 | Length 55 mm | In distribution |
| 152H5508 | Length 55 mm | In distribution |
| 150H8214 | In distribution | |
| 152H5512 | Length 55 mm | In distribution |
| 155H6012 | Width 22 mm | In distribution |
| 153H5008 | Length 50 mm | In distribution |
| 153H6014 | Length 60 mm | In distribution |
| 152H4508 | Length 45 mm | In distribution |
| 155H5514 | Length 55 mm | In distribution |
| 153H6010 | Length 60 mm | In distribution |
| 154H6014 | Length 60 mm | In distribution |
| 153H5514 | Length 55 mm | In distribution |
| 151H6012 | Length 60 mm | In distribution |
| 153H5012 | Length 50 mm | In distribution |
| 155H5010 | Length 50 mm | In distribution |
| 156H5518 | Length 55 mm | In distribution |
| 152H4514 | Length 45 mm | In distribution |
| 151H5514 | Length 55 mm | In distribution |
| 156H6012 | Length 60 mm | In distribution |
| 155H6014 | Width 22 mm | In distribution |
| 155H5510 | Length 55 mm | In distribution |
| 151H5012 | Length 50 mm | In distribution |
| 151H5014 | Length 50 mm | In distribution |
| 156H6014 | Length 60 mm | In distribution |
| 155H6010 | Width 22 mm | In distribution |
| 151H5008 | Length 50 mm | In distribution |
| 150H8200 | In distribution | |
| 152H5012 | Length 50 mm | In distribution |
| 153H5512 | Length 55 mm | In distribution |
| 151H5510 | Length 55 mm | In distribution |
| 151H5512 | Length 55 mm | In distribution |
| 151H6010 | Length 60 mm | In distribution |
| 157H0006 | In distribution | |
| 153H5510 | Length 55 mm | In distribution |
| 150H4512 | Length 45 mm | In distribution |
| 152H5014 | Length 50 mm | In distribution |
| 153H4508 | Length 45 mm | In distribution |
| 151H6008 | Length 60 mm | In distribution |
| 156H5018 | Length 50 mm | In distribution |
| 155H5014 | Length 50 mm | In distribution |
| 157H0003 | In distribution | |
| 152H6012 | Length 60 mm | In distribution |
| 154H5516 | Length 55 mm | In distribution |
| 154H4512 | Length 45 mm | In distribution |
| 154H5010 | Length 50 mm | In distribution |
| 159H4008 | Length 40 mm | In distribution |
| 153H6008 | Length 60 mm | In distribution |
| 150H5008 | Length 50 mm | In distribution |
| 155H4514 | Length 45 mm | In distribution |
| 156H6016 | Length 60 mm | In distribution |
| 150H6014 | Length 60 mm | In distribution |
| 155H5012 | Length 50 mm | In distribution |
| 152H6008 | Length 60 mm | In distribution |
| 150H8208 | In distribution | |
| 154H6012 | Length 60 mm | In distribution |
| 152H6014 | Length 60 mm | In distribution |
| 150H6012 | Length 60 mm | In distribution |
| 156H4518 | Length 45 mm | In distribution |
| 150H5510 | Length 55 mm | In distribution |
| 153H5010 | Length 50 mm | In distribution |
| 153H4510 | Length 45 mm | In distribution |
| 154H5016 | Length 50 mm | In distribution |
| 152H6010 | Length 60 mm | In distribution |
| 153H6012 | Length 60 mm | In distribution |
| 150H8220 | In distribution | |
| 156H5012 | Length 50 mm | In distribution |
| 154H5014 | Length 50 mm | In distribution |
| 156H5514 | Length 55 mm | In distribution |
| 158H4008 | Length 40 mm | In distribution |
| 162H4014 | Length 40 mm | In distribution |
| 151H5508 | Length 55 mm | In distribution |
| 155H4510 | Length 45 mm | In distribution |
| 152H5010 | Length 50 mm | In distribution |
| 156H4516 | Length 45 mm | In distribution |
| 156H4512 | Length 45 mm | In distribution |
| 154H5512 | Length 55 mm | In distribution |
| 154H6010 | Length 60 mm | In distribution |
| 150H4508 | Length 45 mm | In distribution |
| 156H5512 | Length 55 mm | In distribution |
| 150H5014 | Length 50 mm | In distribution |
| 150H5012 | Length 50 mm | In distribution |
| 155H6016 | Width 22 mm | In distribution |
| 153H4512 | Length 45 mm | In distribution |
| 154H4514 | Length 45 mm | In distribution |
| 156H4514 | Length 45 mm | In distribution |
| 152H4512 | Length 45 mm | In distribution |
| 152H5008 | Length 50 mm | In distribution |
| 157H0002 | In distribution | |
| 151H5010 | Length 50 mm | In distribution |
| 150H5010 | Length 50 mm | In distribution |
| 154H6016 | Length 60 mm | In distribution |
| 152H5510 | Length 55 mm | In distribution |
| 153H5508 | Length 55 mm | In distribution |
| 151H6014 | Length 60 mm | In distribution |
| 151H4512 | Length 45 mm | In distribution |
| 161H4014 | Length 40 mm | In distribution |
| 154H4510 | Length 45 mm | In distribution |
| 156H6018 | Length 60 mm | In distribution |
| 154H5514 | Length 55 mm | In distribution |
| 150H6010 | Length 60 mm | In distribution |
| 160H4012 | Length 40 mm | In distribution |
| 150H1100 | In distribution | |
| 152H5514 | Length 55 mm | In distribution |
| 156H5014 | Length 50 mm | In distribution |
| 156H5516 | Length 55 mm | In distribution |
| 152H4510 | Length 45 mm | In distribution |
| 152H4008 | Length 40 mm | In distribution |
| 156H5016 | Length 50 mm | In distribution |
| 151H4508 | Length 45 mm | In distribution |
| 153H5014 | Length 50 mm | In distribution |
| 155H5016 | Length 50 mm | In distribution |
| 150H5512 | Length 55 mm | In distribution |
| 150H6008 | Length 60 mm | In distribution |
| 150H5514 | Length 55 mm | In distribution |
| 150H4510 | Length 45 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 |
|---|---|
| K200969 | 2020-05-21 |
| K193370 | 2020-01-21 |
| K192687 | 2020-01-09 |
| K191408 | 2019-07-10 |
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.