510(k) · Cleared
ClearedLateral Synfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Jan 6, 2014 as substantially equivalent to K072253 (Synthes Spine Co.Lp, 2007) and 4 other predicates after a 245-day review. Its family tree reaches back 14 generations to 1984. 146 later devices descend from it.
- Decided
- Jan 6, 2014
- Review
- 245 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K841189 (1984). 83 ancestors in all. 146 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 2 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 1 generation backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
- This deviceK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 137 of its ownK150673 SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015
- Descendant · 2 generations on · 127 of its ownK162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution…Synthes USA Products, LLC · 2016
- Descendant · 3 generations on · 109 of its ownK171689 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2017
- Descendant · 4 generations on · 108 of its ownK190959 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti…Medtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 5 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
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 backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 3 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
- 2 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
- 1 generation backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
- This deviceK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC · 2015 · cites it directly137descendants
- K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC · 2016 · 2 generations on127descendants
- K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2017 · 3 generations on109descendants
- K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc. · 2019 · 4 generations on108descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 5 generations on102descendants
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 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −3 | K111525 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2011 | — |
| −2 | K113642 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek USA | 2012 | — |
| −1 | K121982 | Sovereign Spinal System | Medtronic Sofamor Danek | 2012 | — |
| 0 (this device) | K131276 | Lateral Synfix | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | 2015 | — |
| +2 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016 | — |
| +3 | K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| +4 | K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +5 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 15 | 0 |
| 2024 | 28 | 0 |
| 2025 | 26 | 0 |
| 2026 | 28 | 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? (5)
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 |
|---|---|---|---|
| * | K072253 | Synfix-LR SpacerSummary page 1…Product Code OVD (Intervertebral Fusion Device with Integrated Fixation, Lumbar) Synthes SynFix-LR.Spacer (K072253) Zimmer Spine BAK Vista Interbody Fusion Cage (P950002 SO014) Predicates: Medtronic SOVEREIGN… | 2007 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…Fixation, Lumbar) Synthes SynFix-LR.Spacer (K072253) Zimmer Spine BAK Vista Interbody Fusion Cage (P950002 SO014) Predicates: Medtronic SOVEREIGN (K 121982) Globus Medical InterContinental (K103382)… | 1996 |
| * | K121982 | Sovereign Spinal SystemSummary page 1…Synthes SynFix-LR.Spacer (K072253) Zimmer Spine BAK Vista Interbody Fusion Cage (P950002 SO014) Predicates: Medtronic SOVEREIGN (K 121982) Globus Medical InterContinental (K103382) DePuy Synthes Falcon Spacer (K 123180)… | 2012 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 1…mer Spine BAK Vista Interbody Fusion Cage (P950002 SO014) Predicates: Medtronic SOVEREIGN (K 121982) Globus Medical InterContinental (K103382) DePuy Synthes Falcon Spacer (K 123180) The DePuy Synthes SYNFIX Lateral isa com… | 2011 |
| * | K123180 | Falcon SpacerSummary page 1…icates: Medtronic SOVEREIGN (K 121982) Globus Medical InterContinental (K103382) DePuy Synthes Falcon Spacer (K 123180) The DePuy Synthes SYNFIX Lateral isa combination radiolucent and radiopaque int… | 2013 |
What descends from it? (146)
See all 1464 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 10 of the 83 ancestors have a recall of any class.
- Of its descendants, K150673 (Synthes (USA) Products, LLC, 2015) has gone furthest, with 137 descendants of its own.
- 27 other devices also cite its predicate K072253.
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. 2014, 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 SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131276 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131276: Lateral Synfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131276
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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