510(k) · Cleared
ClearedACCUFUSE Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Absolute Advantage Medical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 29, 2018 as substantially equivalent to K133218 (Spinal Elements, Inc., 2014) and 5 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Aug 29, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K971730 (1997). 16 ancestors in all, the oldest K914362 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 3 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
- 2 generations backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
- 1 generation backK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
- This deviceK181471 ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −3 | K040197 | Eagle Anterior Cervial Plate System | Depuyacromed | 2004 | — |
| −2 | K082273 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2008 | — |
| −1 | K100070 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2010 | — |
| 0 (this device) | K181471 | ACCUFUSE Cervical System | Absolute Advantage Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (6)
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 |
|---|---|---|---|
| * | K133218 | Crystal ®; Mosaic ®; Vertu ®Summary page 4…• 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate • Crystal, Spinal Elements, Inc. (K133218) Additional Predicate • UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 Devices… | 2014 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 4…te • Crystal, Spinal Elements, Inc. (K133218) Additional Predicate • UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 Devices / K100070) • BAK/C Vista Interbody Fusion, Centerpulse S… | 2004 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 4…• Crystal, Spinal Elements, Inc. (K133218) Additional Predicate • UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 Devices / K100070) • BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech… | 2008 |
| * | K100070 | Uniplate Anterior Cervical Plate SystemSummary page 4…lements, Inc. (K133218) Additional Predicate • UNIPLATE Anterior Cervical Plate System, DePuy Spine, Inc. (K042544 / K082273 Devices / K100070) • BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3) •… | 2010 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…m, DePuy Spine, Inc. (K042544 / K082273 Devices / K100070) • BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3) • CLSP Plate, Synthes, (K000536) The ACCUFUSE Cervical System c… | 2001 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 4…/ K100070) • BAK/C Vista Interbody Fusion, Centerpulse Spine-Tech (P980048 S3) • CLSP Plate, Synthes, (K000536) The ACCUFUSE Cervical System consists of intervertebral body fusion devices along… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 5 other devices also cite its predicate K133218.
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. 2018, 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 ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior…
Read the full statement (212 words)
The ACCUFUSE Cervical System (intervertebral body fusion device) is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACCUFUSE Cervical System implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACCUFUSE Cervical System implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.
The ACCUFUSE Cervical System (cervical plate/screws) is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
•degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
•spondylolisthesis,
•trauma (i.e. fractures or dislocations),
•tumors,
•deformity (defined as kyphosis, lordosis, or scoliosis),
•pseudarthrosis,
•failed previous fusion,
•spinal stenosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181471: ACCUFUSE Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181471
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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