510(k) · Cleared
ClearedSypher Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogennix, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Feb 19, 2015 as substantially equivalent to K120031 (K2m, Inc., 2012) and 3 other predicates after a 231-day review. Its family tree reaches back 13 generations to 1984. 1 later device descends from it.
- Decided
- Feb 19, 2015
- Review
- 231 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 76 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK120031 Chesapeake Spinal SystemK2m, Inc. · 2012
- This deviceK141798 Sypher Spacer SystemBiogennix, LLC · 2015
- Descendant · cites it directly · 0 of its ownK181337 Sypher Spacer SystemBiogennix, LLC · 2018
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 backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 2 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 1 generation backK120031 Chesapeake Spinal SystemK2m, Inc. · 2012
- This deviceK141798 Sypher Spacer SystemBiogennix, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K181337Sypher Spacer SystemBiogennix, LLC · 2018 · cites it directly0descendants
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 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −3 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −2 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −1 | K120031 | Chesapeake Spinal System | K2m, Inc. | 2012 | — |
| 0 (this device) | K141798 | Sypher Spacer System | Biogennix, LLC | 2015 | — |
| +1 | K181337 | Sypher Spacer System | Biogennix, LLC | 2018 | — |
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 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K120031 | Chesapeake Spinal SystemSummary page 5…510k Trade or Proprietary or Model Name Manufacturer Predicate Type Number Chesapeake® Anterior-Lumbar K120031 K2M Primary Stabilization Sys… | 2012 |
| * | K100089 | Synthes T-Pal SpacerSummary page 5…peake® Anterior-Lumbar K120031 K2M Primary Stabilization System K100089 T-PAL Spacer Synthes Additional K103034, Apache™ Lateral Lumbar… | 2010 |
| * | K103034 | Genesys Spine Interbody Fusion SystemSummary page 5…Primary Stabilization System K100089 T-PAL Spacer Synthes Additional K103034, Apache™ Lateral Lumbar Interbody Genesys Spine… | 2010 |
| * | K130913 | Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemSummary page 5…Additional K103034, Apache™ Lateral Lumbar Interbody Genesys Spine Additional K130913 Fusion System PERFORMANCE DATA The Sypher Spacer System has been tested in the following test modes: x… | 2013 |
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 |
|---|---|---|---|
| K181337 | Sypher Spacer System | 2018 | 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 31 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 13 of the 76 ancestors have a recall of any class.
- Of its descendants, K181337 (Biogennix, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K120031.
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 Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141798: Sypher Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141798
Report an extraction error
Are you the manufacturer?
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