510(k) · Cleared
ClearedAckermann Intervertebral Body Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackermann Instrumente GmbH · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 16, 2015 as substantially equivalent to K142347 (Amedica Corp., 2014) and 2 other predicates after a 288-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- Sep 16, 2015
- Review
- 288 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K841189 (1984). 57 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 2 generations backK121892 Phantom Plus Ceramic Cage SystemAmedica Corp. · 2012
- 1 generation backK142347 Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014
- This deviceK143450 Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH · 2015
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 3 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 2 generations backK121892 Phantom Plus Ceramic Cage SystemAmedica Corp. · 2012
- 1 generation backK142347 Amedica Valeo II Interbody Fusion DeviceAmedica Corp. · 2014
- This deviceK143450 Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −3 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −2 | K121892 | Phantom Plus Ceramic Cage System | Amedica Corp. | 2012 | — |
| −1 | K142347 | Amedica Valeo II Interbody Fusion Device | Amedica Corp. | 2014 | — |
| 0 (this device) | K143450 | Ackermann Intervertebral Body Fusion Device | Ackermann Instrumente GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K142347 | Amedica Valeo II Interbody Fusion DeviceSummary page 5…ct Code: MAX, ODP LEGALLY MARKETED DEVICES TO WHICH ACKERMANN IS CLAIMING SUBSTANTIAL EQUIVALENCE: Primary Predicate Device: Amedica Valeo II Interbody Fusion Device (K142347) Additional Predicate Devices: Aesculap CeSpace PEEK Spinal Implant System (K083311) and Aesculap PEEK Spinal Implant Syst… | 2014 |
| * | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion SystemSummary page 5…IVALENCE: Primary Predicate Device: Amedica Valeo II Interbody Fusion Device (K142347) Additional Predicate Devices: Aesculap CeSpace PEEK Spinal Implant System (K083311) and Aesculap PEEK Spinal Implant System (K071983) DEVICE DESCRIPTION: Ackermann Intervertebral Body Fusion Device c|spine and… | 2009 |
| * | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceSummary page 5…II Interbody Fusion Device (K142347) Additional Predicate Devices: Aesculap CeSpace PEEK Spinal Implant System (K083311) and Aesculap PEEK Spinal Implant System (K071983) DEVICE DESCRIPTION: Ackermann Intervertebral Body Fusion Device c|spine and t|spine is an intervertebral body fusion device t… | 2008 |
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 31 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 57 ancestors have a recall of any class.
- 1 other device also cites its predicate K142347.
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. 2015, 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?
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device c|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (250 words)
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device c|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the c|spine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.
When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device t|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The t|spine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143450: Ackermann Intervertebral Body Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143450
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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