510(k) · Cleared
ClearedRoccia Alif, Roccia Tlif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silony Medical GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 11, 2018 as substantially equivalent to K171434 (Silony Medical GmbH, 2017) and 4 other predicates after a 90-day review. Its family tree reaches back 18 generations to 1984. 3 later devices descend from it.
- Decided
- Jul 11, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K841189 (1984). 201 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- 2 generations backK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- 1 generation backK171434 ROCCIA® MultiLIFSilony Medical GmbH · 2017
- This deviceK180963 Roccia Alif, Roccia TlifSilony Medical GmbH · 2018
- Descendant · cites it directly · 1 of its ownK212075 ShurFit Lumbar Interbody SystemPrecision Spine, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK221172 FOCUS Interbody SystemOc Medical Devices · 2022
- Descendant · cites it directly · 0 of its ownK190680 Favo S-TlifSilony Medical GmbH · 2019
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 8 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 7 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 6 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 5 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 4 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 3 generations backK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- 2 generations backK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
- 1 generation backK171434 ROCCIA® MultiLIFSilony Medical GmbH · 2017
- This deviceK180963 Roccia Alif, Roccia TlifSilony Medical GmbH · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −8 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −7 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −6 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −5 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| −2 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
| −1 | K171434 | ROCCIA® MultiLIF | Silony Medical GmbH | 2017 | — |
| 0 (this device) | K180963 | Roccia Alif, Roccia Tlif | Silony Medical GmbH | 2018 | — |
| +1 | K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021 | — |
| +2 | K221172 | FOCUS Interbody System | Oc Medical Devices | 2022 | — |
| +1 | K190680 | Favo S-Tlif | Silony Medical GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 21 | 0 |
| 2005 | 15 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 26 | 0 |
| 2009 | 14 | 0 |
| 2010 | 13 | 0 |
| 2011 | 13 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171434 | ROCCIA® MultiLIFSummary page 4…l Fusion Device with Bone Graft, Thoracic Device Class: Class II Classification Panel: Orthopedic 5. Predicate Devices Primary Predicate: K171434, ROCCIA® MultiLIF Cage, Silony Medical Additional Predicate: K141217, AccuLIF® TL and PL Cage, Stryker Additional Predicate… | 2017 |
| * | K141217 | Acculif TL and PL CageSummary page 4…Class II Classification Panel: Orthopedic 5. Predicate Devices Primary Predicate: K171434, ROCCIA® MultiLIF Cage, Silony Medical Additional Predicate: K141217, AccuLIF® TL and PL Cage, Stryker Additional Predicate: K072253, SynFix-LR, Synthes Additional Predicate: K151214, ALIF Int… | 2014 |
| * | K072253 | Synfix-LR SpacerSummary page 4…Devices Primary Predicate: K171434, ROCCIA® MultiLIF Cage, Silony Medical Additional Predicate: K141217, AccuLIF® TL and PL Cage, Stryker Additional Predicate: K072253, SynFix-LR, Synthes Additional Predicate: K151214, ALIF Interfixed System, NuVasive® Additional Predicate: K153720, ENZA Ze… | 2007 |
| * | K151214 | ALIF Interfixated SystemSummary page 4…LIF Cage, Silony Medical Additional Predicate: K141217, AccuLIF® TL and PL Cage, Stryker Additional Predicate: K072253, SynFix-LR, Synthes Additional Predicate: K151214, ALIF Interfixed System, NuVasive® Additional Predicate: K153720, ENZA Zero-Profile Anterior IBFD, Camber Spine === Page 5 ==… | 2015 |
| * | K153720 | ENZA Zero-Profile Anterior Interbody FusionSummary page 4…TL and PL Cage, Stryker Additional Predicate: K072253, SynFix-LR, Synthes Additional Predicate: K151214, ALIF Interfixed System, NuVasive® Additional Predicate: K153720, ENZA Zero-Profile Anterior IBFD, Camber Spine… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 25 of the 201 ancestors have a recall of any class.
- Of its descendants, K212075 (Precision Spine, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment. The ROCCIA TLIF Cage implants are intended for use…
Read the full statement (202 words)
The ROCCIA TLIF and ROCCIA ALIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.
The ROCCIA TLIF Cage implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
The ROCCIA TLIF and ROCCIA ALIF Cage implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180963: Roccia Alif, Roccia Tlif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180963
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026