510(k) · Cleared
ClearedAncora LLC Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frontier Medical Devices, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Feb 26, 2015 as substantially equivalent to K112700 (Frontier Medical Devices, Inc., 2012) and 2 other predicates after a 108-day review. Its family tree reaches back 15 generations to 1984.
- Decided
- Feb 26, 2015
- Review
- 108 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 94 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- This deviceK143228 Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2015
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 2 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 1 generation backK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- This deviceK143228 Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −2 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −1 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| 0 (this device) | K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 13 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K112700 | Frontier Sadl Interbody Fusion DeviceSummary page 4…device Predicate Devices The Ancora LLC was shown to be substantially equivalent to legally marketed predicate devices. The primary predicate device is the Ancora LLC (K112700). Additional predicate devices are the CoRoent XL‐F Device (K140479), and the BAK Device (P950002). Device Description The Ancor… | 2012 |
| * | K140479 | Coroent XL-F SystemSummary page 4…lly equivalent to legally marketed predicate devices. The primary predicate device is the Ancora LLC (K112700). Additional predicate devices are the CoRoent XL‐F Device (K140479), and the BAK Device (P950002). Device Description The Ancora system consists of different footprints and heights to provide opt… | 2014 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 4…eted predicate devices. The primary predicate device is the Ancora LLC (K112700). Additional predicate devices are the CoRoent XL‐F Device (K140479), and the BAK Device (P950002). Device Description The Ancora system consists of different footprints and heights to provide options that correlate best to an… | 1996 |
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 13 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 94 ancestors have a recall of any class.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the…
Read the full statement (146 words)
The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143228: Ancora LLC Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143228
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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