510(k) · Cleared
ClearedRoccia® Acif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silony Medical GmbH · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jan 26, 2017 as substantially equivalent to K150362 (Nu Vasive, Incorporated, 2015) after a 132-day review. Its family tree reaches back 14 generations to 1984. 1 later device descends from it.
- Decided
- Jan 26, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K841189 (1984). 47 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 2 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 1 generation backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- This deviceK162587 Roccia® AcifSilony Medical GmbH · 2017
- Descendant · cites it directly · 0 of its ownK182608 Oyster ACIF CageSilony Medical GmbH · 2019
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 8 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 7 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 6 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 5 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 4 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 3 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 2 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 1 generation backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- This deviceK162587 Roccia® AcifSilony Medical GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K182608Oyster ACIF CageSilony Medical GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −8 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −7 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −6 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −5 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −4 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −3 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −2 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −1 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K162587 | Roccia® Acif | Silony Medical GmbH | 2017 | — |
| +1 | K182608 | Oyster ACIF Cage | 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 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K150362 | NuVasive CoRoent Small Interbody SystemSummary page 5…ith Bone Graft, Cervical Device Class: Class II Classification Panel: Orthopedic 5. Legally Marketed Predicate Device Primary Predicate: K150362, NuVasive CoRoent Small Interbody System, NuVasive Incorporated 6. Device Description The ROCCIA ACIF was developed for prim… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182608 | Oyster ACIF Cage | 2019 | 0 |
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 33 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 47 ancestors have a recall of any class.
- Of its descendants, K182608 (Silony Medical GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K150362.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The ROCCIA ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCIA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System…
Read the full statement (116 words)
The ROCCIA ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCIA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162587: Roccia® Acif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162587
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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