OneLIF™
The OneLIF Intervertebral Body Replacement System is an interbody fusion system for skeletally mature patients at lumbosacral levels L2 to S1. Its cages include six holes designed to accept…
The OneLIF Intervertebral Body Replacement System is an interbody fusion system for skeletally mature patients at lumbosacral levels L2 to S1. Its cages include six holes designed to accept bone screws, and the filing describes use with or without accompanying screws.
Standalone use is conditional: at one or two contiguous levels, the filing specifies at least three screws per implant, including one in each endplate, and implants with no more than 20 degrees of lordosis. Other circumstances require posterior fixation.
Listed Item
Bone Screw Srewdriver Blade-Str Tip, 1/4″ Drive, T15 (retaining)
Use Conditions
The indication includes degenerative disc disease, deformity, spondylolisthesis or retrolisthesis and failed prior fusion. The filing specifies six months of non-operative treatment and autograft or allogeneic bone graft.
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Novapproach Spine, LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K211769 |
| Record published | 2022-07-08 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 013-320-1122 | In distribution | |
| 011-225-1807 | In distribution | |
| 010-107-1209 | In distribution | |
| 010-225-1807 | In distribution | |
| 013-310-1222 | In distribution | |
| 011-107-1007 | In distribution | |
| 011-713-0005 | In distribution | |
| 013-311-1222 | In distribution | |
| 011-713-0003 | In distribution | |
| 011-513-0003 | In distribution | |
| 010-219-1810 | In distribution | |
| 010-119-1407 | In distribution | |
| 012-006-4716 | In distribution | |
| 012-003-4016 | In distribution | |
| 013-300-1122 | In distribution | |
| 013-311-1000 | In distribution | |
| 010-213-1206 | In distribution | |
| 011-213-1206 | In distribution | |
| 010-313-2013 | In distribution | |
| 015-024-0000 | In distribution | |
| 012-001-4024 | In distribution | |
| 010-213-1610 | In distribution | |
| 013-130-1218 | In distribution | |
| 010-219-1608 | In distribution | |
| 010-207-1411 | In distribution | |
| 013-310-1000 | In distribution | |
| 013-300-1222 | In distribution | |
| 015-013-0000 | In distribution | |
| SPX-011-613-1107 | In distribution | |
| 011-125-1606 | In distribution | |
| 010-307-1006-2 | In distribution | |
| 011-307-1006 | In distribution | |
| 011-513-0005 | In distribution | |
| 012-001-4520 | In distribution | |
| 015-016-0000 | In distribution | |
| 013-321-1222 | In distribution | |
| 015-040-0000 | In distribution | |
| 011-207-1007 | In distribution | |
| 013-110-1218 | In distribution | |
| 012-003-4024 | In distribution | |
| 015-007-0000 | In distribution | |
| 011-219-1608 | In distribution | |
| 013-100-1000 | In distribution | |
| 012-003-4028 | In distribution | |
| 011-119-1811 | In distribution | |
| 013-110-1001 | In distribution | |
| 010-307-1410 | In distribution | |
| 012-005-4720 | In distribution | |
| 014-100-0000 | In distribution | |
| 013-200-1119 | In distribution | |
| 011-613-0003 | In distribution | |
| 012-003-4020 | In distribution | |
| 013-120-1218 | In distribution | |
| 010-207-1613 | In distribution | |
| 012-001-4516 | In distribution | |
| 013-331-1222 | In distribution | |
| 010-313-1609 | In distribution | |
| 010-219-1406 | In distribution | |
| 010-325-2007 | In distribution | |
| 011-613-0005 | In distribution | |
| 013-121-1118 | In distribution | |
| 015-018-0000 | In distribution | |
| 011-325-2007 | In distribution | |
| 010-107-1007 | In distribution | |
| 014-000-0000 | In distribution | |
| 010-113-1006-2 | In distribution | |
| 013-320-1222 | In distribution | |
| 015-025-0000 | In distribution | |
| 013-320-1000 | In distribution | |
| 011-513-0004 | In distribution | |
| 013-121-1001 | In distribution | |
| 013-220-1220 | In distribution | |
| 012-006-4720 | In distribution | |
| 013-210-1119 | In distribution | |
| 012-003-4516 | In distribution | |
| 013-211-1119 | In distribution | |
| 013-111-1001 | In distribution | |
| 013-221-1000 | In distribution | |
| SPX-015-044-0000 | In distribution | |
| 012-001-4028 | In distribution | |
| 010-307-1208 | In distribution | |
| 013-221-1220 | In distribution | |
| 013-120-1001 | In distribution | |
| 011-307-1208 | In distribution | |
| 011-113-1612 | In distribution | |
| 013-310-1122 | In distribution | |
| 015-004-0000 | In distribution | |
| 011-313-1609 | In distribution | |
| 012-005-4716 | In distribution | |
| 015-017-0000 | In distribution | |
| 011-319-1808 | In distribution | |
| 010-313-1811 | In distribution | |
| 011-325-2209 | In distribution | |
| 013-100-1218 | In distribution | |
| 010-107-1411 | In distribution | |
| 011-713-0004 | In distribution | |
| 010-113-1612 | In distribution | |
| 010-213-1812 | In distribution | |
| 013-220-1119 | In distribution | |
| 011-713-0002 | In distribution | |
| 015-044-0000 | In distribution | |
| 012-001-4020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251459 | 2025-06-12 |
| K211769 | 2021-09-07 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Novapproach Spine, LLC | 510(k) number | 2026-04-23 | Class II | Process design | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to sele | 1259 | |
| Novapproach Spine, LLC | 510(k) number | 2022-10-12 | Class II | Nonconforming Material/Component | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. | 6 devices | 2026-04-01 |
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.